Generic placeholder image

Current Pharmaceutical Analysis

Author(s): Saloni Desai*, Rajnikant Bhikhubhai Maradia and Bhanubhai N Suhagia

DOI: 10.2174/1573412918666221010111801

DownloadDownload PDF Flyer Cite As
A Comprehensive and Critical Review on Analytical and Bioanalytical methods for Metformin Hydrochloride, Dapagliflozin, and Saxagliptin

Page: [20 - 50] Pages: 31

  • * (Excluding Mailing and Handling)

Abstract

A new antidiabetic drug combination of Metformin Hydrochloride, Dapagliflozin, and Saxagliptin have been recently approved for type II diabetes. This is marketed by Takeda Pharmaceuticals under the brand name Qternmet XR. Although different analytical and bioanalytical methods using different techniques such as liquid chromatography, high-performance liquid chromatography, high-performance thin-layer chromatography, gas chromatography, spectrophotometry, spectrofluorimetric methods coupled with ultraviolet, fluorescence, mass, or tandemmass spectrometry detection have already been developed for the determination of Metformin Hydrochloride, Dapagliflozin, and Saxagliptin. Sensitive, cost-effective, and more optimized methods are yet required. Therefore, this review summarizes the main analytical and bioanalytical aspects regarding not only simultaneous estimation but also stability-indicating methods, kinetic studies, and impurity analysis for the analysis of proposed drugs in bulk and pharmaceutical dosage forms. Thus, this review gathers, for the first time, important background information on all analytical and bioanalytical methods that have been developed and applied for the determination of Metformin Hydrochloride, Dapagliflozin, and Saxagliptin, which should be considered as a starting point if new techniques are aimed to be implemented for these drugs.

Graphical Abstract

[1]
Tripathi, K.D. Essential of medical pharmacology; Jaypee Digital: New Delhi, India, 2013.
[http://dx.doi.org/10.5005/jp/books/12256]
[2]
I.D.F. Diabetes atlas. International Diabetes Federation. 2021. Available from: https://diabetesatlas.org/#:~:text=Diabetes%20around%20the%20world%20in%202021%3A,%2D%20and%20middle%2Dincome%20countries
[3]
Medicine; ; Forouhi, N.G.; Wareham, N.J. Epidemiology of diabetes. Elsevier Ltd,, 2014, 42, pp. 698-702.
[4]
Colin, T. Diabetes Mellitus, 2016. Available from: patient.info/doctor/diabetes(Accessed on: 2022 Feb 12).
[5]
Ministry of Health and Family Welfare. Indian Pharmacopoeia Government of India 8th ed.; The Indian Pharmacopoeia Commission: Gaziabad; , 2018, 2, pp. 1658-1659.
[6]
Wishart, D.S.; Feunang, Y.D.; Guo, A.C. Drug profile of Dapagliflozin; , 2018. Available from: www.drugbank.ca/salts/DBSALT001101
[7]
Wishart, D.S.; Feunang, Y.D.; Guo, A.C. lo, E.J.; Marcu, A.; Grant, J.R. Drug profile of Saxagliptin 2018. Available from: https://www.drugbank.ca/salts/DBSALT000158
[8]
Vath, M.; Gallagher, L.; Shou, W.; Weller, H.; Elkin, L.; Zhang, J. Development of an LC–MS/MS method for high throughput quantification of metformin uptake in transporter inhibition assays. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2014, 967, 211-218.
[http://dx.doi.org/10.1016/j.jchromb.2014.07.024] [PMID: 25125398]
[9]
Mikam, N. Analytical method development and validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines. Int. J. Trend Sci. Res. Develop., 2019, 3(3), 415-419.
[10]
Rele, R.v.; Patil, S.P. Application of RP-HPLC technique for development of analytical method for validation of metformin hydrochloride from bulk drug and dosage form. Asian J. Res. Chem, 2021, 14(4), 265-268.
[11]
Sowjanya, P. RP-HPLC Method development of metformin in pharmaceutical dosage form. J. Pharm. Anal., 2015, 4(4), 9-20.
[12]
Al-Rimawi, F. Development and validation of an analytical method for metformin hydrochloride and its related compound (1-cyanoguanidine) in tablet formulations by HPLC-UV. Talanta, 2009, 79(5), 1368-1371.
[http://dx.doi.org/10.1016/j.talanta.2009.06.004] [PMID: 19635372]
[13]
Gadipally, S. Method Development of Metformin Hydrochloride RP-HPLC. World J. Pharm. Pharm. Sci., 2014, 3(3), 1149-1159.
[14]
Madhukar, A.; Prince, A.; Kumar, V.R.; Raghupratap, D. Simple and sensitive analytical method development and validation of Metformin Hydrochloride by RP-HPLC. Int. J. Pharm. Pharm. Sci., 2011, 3(3), 117-120.
[15]
Kar, M.; Choudhury, P.K. HPLC method for estimation of metformin hydrochloride in formulated microspheres and tablet dosage form. Indian J. Pharm. Sci., 2009, 71(3), 318-320.
[http://dx.doi.org/10.4103/0250-474X.56031] [PMID: 20490303]
[16]
Hamdan, I.I.; Jaber, A.K.B.; Abushoffa, A.M. Development and validation of a stability indicating capillary electrophoresis method for the determination of metformin hydrochloride in tablets. J. Pharm. Biomed. Anal., 2010, 53(5), 1254-1257.
[http://dx.doi.org/10.1016/j.jpba.2010.03.017] [PMID: 20395106]
[17]
Mishra, K.; Soni, H.; Nayak, G.; Patel, S.S.; Singhai, A.K. Method development and validation of metformin hydrochloride in tablet dosage form. E-J. Chem., 2011, 8(3), 1309-1313.
[http://dx.doi.org/10.1155/2011/768014]
[18]
Dange, Y.D.; Honmane, S.M.; Bhinge, S.D.; Salunkhe, V.R.; Jadge, D.R. Development and validation of uv-spectrophotometric method for estimation of metformin in bulk and tablet dosage form. Indian J. Pharmaceut. Edu. Res., 2017, 51(4s), s754-s760.
[http://dx.doi.org/10.5530/ijper.51.4s.109]
[19]
Judeh, A.A.; Sarief, A.; Umar, Y.; Ashwaq, O.; Haque, S.M. Development, computational study and validation of spectrophotometric method of Metformin Hydrochloride in pharmaceutical formulations. J. Chil. Chem. Soc., 2020, 65(3), 4895-4899.
[http://dx.doi.org/10.4067/s0717-97072020000204895]
[20]
Shakoor, A.; Ahmed, M.; Ikram, R.; Hussain, S.; Tahir, A.; Jan, B.M.; Adnan, A. Stability-indicating RP-HPLC method for simultaneous determination of metformin hydrochloride and vildagliptin in tablet and biological samples. Acta Chromatogr., 2020, 32(1), 39-43.
[http://dx.doi.org/10.1556/1326.2019.00555]
[21]
Raza, A.; Hassan Murtaza, S.; Hanif, S.; Iqbal, J.; Ali, I. Validation of a rapid and economical RP-HPLC method for simultaneous determination of metformin hydrochloride and sitagliptin phosphate monohydrate: Greenness evaluation using AGREE score. Pak. J. Pharm. Sci., 2022, 351, 15-21.
[22]
Vasa, R.; Vasa, N.; Tiwari, N.; Patani, P.; Solanki, B. Development and validation of stability indicating Rp-Hplc method for estimation of Metformin Hcl and Remogliflozin Etabonate in pharmaceutical dosage form. Int. J. All Res. Edu. Sci. Methods, 2021, 9, 66.
[23]
Snehal Bapusaheb, B.; Prerana, J.B. Development and validation of RP-HPLC method for simultaneous estimation of metformin hydrochloride and glipizide in bulk and pharmaceutical dosage form. J. Drug Deliv. Ther., 2019, 9(3S), 146-155.
[24]
Susmita, A.G.; Rajitha, G.; Yadav, R.Y.; Pathipati, U. Analytical method development and validation of new stability indicating Reverse-phase High Performance Liquid Chromatography method for simultaneous estimation of Metformin Hydrochloride and Empagliflozin in tablet dosage form. Asian J. Pharm. Clin. Res., 2019, 12(1), 241.
[http://dx.doi.org/10.22159/ajpcr.2019.v12i1.26537]
[25]
Rana, K.; Sharma, P. Analytical method development and validation for the simultaneous estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Science and Technology, 2021, 13(2), 111-118.
[http://dx.doi.org/10.52711/2349-2988.2021.00017]
[26]
Gedawy, A.; Al-Salami, H.; Dass, C.R. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, metformin and gliclazide. Yao Wu Shi Pin Fen Xi, 2019, 27(1), 315-322.
[PMID: 30648585]
[27]
Khoja, S.S.; Patel, L.J. Development and validation of new RP-HPLC method for the estimation of antidiabetic drugs metformin hydrochloride and gemigliptin in combined pharmaceutical dosage form. J. Pharm. Res. Int., 2021, 33(30), 149-160.
[http://dx.doi.org/10.9734/jpri/2021/v33i30B31649]
[28]
Kumari, K.S.; Bandhakavi, S. Development and validation of stability-indicating RP-HPLC method for the simultaneous determination of ertugliflozin pidolate and metformin hydrochloride in bulk and tablets. Future J. Pharmaceut. Sci., 2020, 6(1), 66.
[http://dx.doi.org/10.1186/s43094-020-00079-1]
[29]
Musmade, B.D.; Baraskar, M.L.; Ghodke, V.N.; Bhope, S.G.; Padmanabhan, S.; Lohar, K.S. Impurity profiling method development and validation of metformin hydrochloride and teneligliptin hydrobromide hydrate in their combination tablet dosage form by using RP-HPLC with UV/PDA detector. Future J. Pharmaceut. Sci., 2021, 7(1), 218.
[http://dx.doi.org/10.1186/s43094-021-00362-9]
[30]
Nagalakshmi, V.; Srinivas Rao, G.; Devi, N.G.; Mohan, S. Rp-hplc method for simultaneous estimation of vildagliptin and metformin in bulk and pharmaceutical formulations. Int. J. Curr. Res. Rev., 2021, 13(7), 112-117.
[http://dx.doi.org/10.31782/IJCRR.2021.13710]
[31]
Mahrouse, M.A.; Lamie, N.T. Experimental design methodology for optimization and robustness determination in ion pair RP-HPLC method development: Application for the simultaneous determination of metformin hydrochloride, alogliptin benzoate and repaglinide in tablets. Microchem. J., 2019, 147, 691-706.
[http://dx.doi.org/10.1016/j.microc.2019.03.038]
[32]
Pandit, V.; Pai, R.S.; Singh, G.; Devi, K.; Narayana, S.; Suresh, S. Development and validation of the liquid chromatographic method for simultaneous estimation of metformin, pioglitazone, and glimepiride in pharmaceutical dosage forms. Pharm. Methods, 2012, 3(1), 9-13.
[http://dx.doi.org/10.4103/2229-4708.97707] [PMID: 23781471]
[33]
Nirupa, G.; Tripathi, U.M. RP-HPLC analytical method development and validation for simultaneous estimation of three drugs: Glimepiride, pioglitazone, and metformin and its pharmaceutical dosage forms. J. Chem., 2013, 2013, 726235.
[http://dx.doi.org/10.1155/2013/726235]
[34]
Shaikh, F.A.; Gawai, A.A. National Conference on Recent Trends in Synthesis and Characterization of Futuristic Material in Science for the Development of Society. [NCRDAMDS-2018] Int. J. Sci. Res. Sci. Technol., 2018, 4(1), 110-113.
[35]
Machairas, G.; Panderi, I.; Geballa-Koukoula, A.; Rozou, S.; Antonopoulos, N.; Charitos, C.; Vonaparti, A. Development and validation of a hydrophilic interaction liquid chromatography method for the quantitation of impurities in fixed-dose combination tablets containing rosuvastatin and metformin. Talanta, 2018, 183, 131-141.
[http://dx.doi.org/10.1016/j.talanta.2018.02.068] [PMID: 29567155]
[36]
Sheikh, I.A.; Chakole, R.D.; Charde, M.S. Application of Validated HPLC Method for Degradation Study of Sitagliptin and Metformin HCl. Int. J. Adv. Pharmaceut. Anal., 2017, 07(02), 21-24.
[http://dx.doi.org/10.7439/ijapa.v7i2.4375]
[37]
Jadhav, S.; Reddy, P.; Narayanan, K.; Bhosale, P. Development of RP-HPLC, stability indicating method for degradation products of linagliptin in presence of metformin HCL by applying 2 level factorial design; and identification of impurity-VII, VIII and IX and synthesis of impurity-VII. Sci. Pharm., 2017, 85(3), 25.
[http://dx.doi.org/10.3390/scipharm85030025] [PMID: 28653975]
[38]
Vasantharaju, S.G.; Shushmitha, G.S.; Krishna, M.; D’souza, S. Stability Indicating Assay Method Development andValidation to Simultaneously Estimate Metform in Hydrochloride and Canagliflozin by RP-HPLC. Curr. Trends Biotechnol. Pharm., 2016, 10(4), 334-342.
[39]
Yardımcı C.; Özaltın, N. Method development and validation for the simultaneous determination of rosiglitazone and metformin in pharmaceutical preparations by capillary zone electrophoresis. Anal. Chim. Acta, 2005, 549(1-2), 88-95.
[http://dx.doi.org/10.1016/j.aca.2005.06.014]
[40]
Ayoub, B.M. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2016, 168, 118-122.
[http://dx.doi.org/10.1016/j.saa.2016.06.010] [PMID: 27288963]
[41]
Jayasundara, U.K.; Herath, H.; Kaushalya, P. Method Development, Validation, and Concentration Determination of Metformin Hydrochloride and Atorvastatin Calcium Using UV-Visible Spectrophotometry. J. Anal. Bioanal. Tech., 2021, 12(2), 428.
[42]
Kalyankar, T.M.; Sasatte, S.; Bodhankar, M.R. Development and validation of stability indicating assay method for simultaneous estimation of metformin and teneligliptin hydrobroide combined dosage form. J. Emerg. Technol. Innov. Res., 2020, 7(3), JETIRDN06020.
[43]
Sen, A.; Hinsu, D.; Sen, D.; Zanwar, A.; Maheshwari, R.; Chandrakar, V. Analytical method development and validation for simultaneous estimation of Teneligliptin hydrobromide hydrate and Metformin hydrochloride from it’s pharmaceutical dosage form by three different UV spectrophotometric methods. J. Appl. Pharm. Sci., 2016, 6(9), 157-165.
[http://dx.doi.org/10.7324/JAPS.2016.60924]
[44]
Majithia, R.H.; Khodadiya, D.A.; Patel, V.B. Spectrophotometric method development and validation for simultaneous estimation of Anagliptin and Metformin HCl BY Q - Absorption ratio method in synthetic mixture. Heliyon, 2020, 6(5), e03855.
[http://dx.doi.org/10.1016/j.heliyon.2020.e03855] [PMID: 32405546]
[45]
Ravindra Harnaskar, V.; Datar, P.A. A review on analysis of Dapagliflozin. Curr. Pharm., 2018, 8, 87254115.
[46]
Kalyan, S.; Parle, A. A validated LC-MS/MS method for determination of Dapagliflozin in tablet formulation. IOSR J. Pharm., 2019, 9(8), 1-6.
[47]
Grace, A.C.; Thangavelu, P.; Sivakumar, T. Development and validation of High Perfomance Liquid Chromatographic method for determination of Dapagliflozin and it’s impurities in tablet dosage form. Asian J. Pharm. Clin. Res., 2019, 12(3), 447-453.
[http://dx.doi.org/10.22159/ajpcr.2019.v12i3.30853]
[48]
Atul, T.H.; Narendra, D. Development and validation of dissolution test method for dapagliflozin using RP-HPLC and UV spectrophotometer. IJPRS, 2020, 9, 1-2.
[49]
Nilesh, P.; Sejal, P. Reverse phase high performance liquid chromatographic method for separation and estimation of impurities present in pharmaceutical formulation of Dapaglifozin. Ann. Chromatogr. Separat. Techn., 2018, 4(1), 1033.
[50]
Jeyabaskaran, M.; Dhanalakshmi, B. RP-HPLC Method development and validation of Dapagliflozin in Bulk and Tablet formulation. Int. J. Pharm. Anal. Res., 2013, 2(4), 1-6.
[51]
Debata, J.; Kumar, S.; Jha, S.K. A New RP-HPLC method development and validation of dapagliflozin in bulk and tablet dosage form. Int. J. Drug Develop. Res., 2017, 9(2), 1-6.
[52]
Manasa, S.; Reddy, N.G. Method Development and Validation of Dapagliflozin in API by RP-HPLC and UV-Spectroscopy. Int. J. Pharm. Sci. Drug Res., 2014, 6, 1755-1759.
[53]
Sarkar, S.; Patel, V.D.; Sarkar, S.; Patel, V.P. All rights reserved. Int. J. Pharm. Res. Health Sci., 2017, 5(4), 1755-1759.
[54]
Manoharan, G.; Ismaiel, A.M.; Ahmed, Z.M. CRJHA5 stability-indicating RP-HPLC method development for simultaneous determination and estimation of dapagliflozin in raw and tablet formulation. Chem. Res. J., 2018, 3(2), 159-164.
[55]
Sanagapati, M.; Dhanalakshmi, K.; Reddy Nagarjuna, G.; Sreenivasa, S. Development and validation of stability-indicating RP-HPLC method for determination of Dapagliflozin. J. Adv. Pharm. Educ. Res., 2014, 4(3), 350-353.
[56]
Verma, M.V.; Patel, C.J.; Patel, M.M. Development and stability indicating HPLC method for dapagliflozin in API and pharmaceutical dosage form. Int. J. Appl. Pharmaceut., 2017, 9(5), 33-41.
[http://dx.doi.org/10.22159/ijap.2017v9i5.19185]
[57]
Meira, R.Z.C.; Mendes, C.; Silva, M.A.S.; Bernardi, L.S.; Oliveira, P.R. Development and validation of a Stability Indicating HPLC method for determination of Dapagliflozin in tablets. New J. Chem., 2018, 42, 459-2466.
[58]
Shakirbasha, S.P.S. Development and validation of dapagliflozin by reversed-phase high-performance liquid chromatography method and it’s forced degradation studies. Asian J. Pharm. Clin. Res., 2017, 10(11), 101-105.
[http://dx.doi.org/10.22159/ajpcr.2017.v10i11.19705]
[59]
Pharma, D.; Sura, S.; Rao Modalavalasa, R.; Kothapalli, C.B. Validation of a newly developed stability indicating RP-Liquid Chromatographic Method for the Quantitative Determination of Dapagliflozin. Der Pharma Chem., 2018, 10, 93-102.
[60]
Yavantika, V.v.; Patani, P.; Patel, D.; Pharm, M. Development and validation of stability indicating estimation method of dapagliflozin in it’s tablet dosage form. Int. J. Res. Anal. Rev., 2019, 6(2), 206-213.
[61]
Karmankar, S.R.; Tajne, M.R. A validated stability indicating high performance thin layered chromatographic method for the analysis of dapagliflozin in bulk drug and marketed tablet formulation. Asian J. Chem., 2019, 31(7), 1457-1460.
[http://dx.doi.org/10.14233/ajchem.2019.21824]
[62]
Sree, N. Method development and validation for the estimation of dapagliflozin in bulk and tablet dosage formby UV Visible Spectroscopy. Int. J. Recent Sci. Res., 2019, 10(08), 34419-34422.
[63]
Mante, G.V.; Gupta, K.R.; Hemke, A.T. Estimation of Dapagliflozin from its Tablet Formulation by UV-Spectrophotometry. Pharm. Methods, 2017, 8(2), 102-107.
[http://dx.doi.org/10.5530/phm.2017.8.16]
[64]
Chitra, K.P.; Eswaraiah, M.C.; Rao, M.V.B. Unique UV spectrophotometric method for reckoning of dapagliflozin in bulk and pharmaceutical dosage forms. J. Chem. Pharm. Res., 2015, 7(9), 45-49.
[65]
Omar, M.A.; Abdel Hamid, M.A.; Batakoushy, H.A.; Ahmed, H.M. Second derivative synchronous spectrofluorimetric assay of dapagliflozin: Application to stability study and pharmaceutical preparation. Luminescence, 2020, 35(2), 260-265.
[http://dx.doi.org/10.1002/bio.3722] [PMID: 31733037]
[66]
Dave, V.S.; Patel, P.U. Development and validation of UV Spectroscopic method for Dapagliflozin in its API and its Tablet Formulation. Aegaeum J., 2020, 8(5), 840-846.
[67]
Patel, A.; Maheshwari, D.; Pharm, M. Chromatographic and Spectrophotometric Methods for estimation of Dapagliflozin and Glimepirirde in bulk and in different dosage forms. Asian J. Pharmaceut. Technol. Innovat., 2017, 22, 16-26.
[68]
Hassib, S.T.; Taha, E.A.; Elkady, E.F.; Barakat, G.H. Validated Liquid Chromatographic Method for the Determination of (Canagliflozin, Dapagliflozin or Empagliflozin) and Metformin in the Presence of (1-Cyanoguanidine). J. Chromatogr. Sci., 2019, 57(8), 697-707.
[http://dx.doi.org/10.1093/chromsci/bmz042] [PMID: 31240304]
[69]
Salama, I.; Khalil, G.A.; Gomaa, M.S.; Helal, M.A. Validated RP-HPLC method for simultaneous determination of Canagliflozin, Dapagliflozin, Empagliflozin and Metformin. Int. J. Pharm. Chem. Biol. Sci., 2018, 8(1), 1-13.
[70]
Patel, A.; Maheshwari, D. Development and validation of UV Spectrophotometric method and RP-HPLC method for simultaneous estimation of Dapagliflozin Propanediol and Glimepiride in synthetic mixture. Eur. J. Pharm. Med. Res., 2017, 4(7), 649-664.
[71]
Sridhar, L.; Goutami, P.; Darshan, D.V.; Ramakrishna, K.; Rao, R.N.; Prabhakar, S. LC-ESI-MS/MS studies on saxagliptin and its forced degradation products. Anal. Methods, 2014, 6(20), 8212-8221.
[http://dx.doi.org/10.1039/C4AY01152J]
[72]
Abdel-Ghany, M.F.; Abdel-Aziz, O.; Ayad, M.F.; Tadros, M.M. Stability-indicating liquid chromatographic method for determination of saxagliptin and structure elucidation of the major degradation products using LC-MS. J. Chromatogr. Sci., 2015, 53(4), 554-564.
[http://dx.doi.org/10.1093/chromsci/bmu084] [PMID: 25060753]
[73]
Karkhanis Vaishali, V.; Captain Anandkumari, D. Development and Validation of a Liquid Chromatographic Method for Estimation of Saxagliptin in Tablet dosage form. Asian J. Res. Chem, 2013, 6(6), 552-554.
[74]
Islam, M.S.; Hossain, M.T.; Kumar Kundu, S.; Halim, A. Development and validation of RP-HPLC Method for determination of saxagliptin hydrochloride in bulk and tablet dosage form. World J. Pharm. Pharmaceut. Sci. SJIF, 2016, 5(5), 107-119.
[75]
Zinjad, S.S.; Gaikwad, D.D.; Jadhav, S.L. Analytical Method Development of Saxagliptin HCl by RP-HPLC. J. Drug Deliv. Ther., 2019, 9(4), 274-278.
[76]
Daswadkar, S.C.; Roy, M.A.; Walode, S.G.; Kumar, M. Quality By Design approach for the development and validation of Saxagliptin by RP HPLC with application to formulated forms. Int. J. Pharm. Sci. Res., 2016, 7(4), 1670-1677.
[http://dx.doi.org/10.13040/IJPSR.0975-8232.7]
[77]
Scheeren, L.E.; Marcolino, A.I.P.; Adams, A.I.H.; Rolim, C.M.B. Stability indicating RP-LC-PDA method for the quantitative analysis of saxagliptin in pharmaceutical dosage form. Braz. J. Pharm. Sci., 2015, 51(2), 461-466.
[http://dx.doi.org/10.1590/S1984-82502015000200023]
[78]
Farooqui, F.I.; Kakde, R.B. Reversed-phase liquid chromatography with mass detection and characterization of saxagliptin degradation related impurities. J. Chem. Pharm. Res., 2016, 8(7), 509-514.
[79]
Rao, N.; Kishore, B.; Pn, H.; Kumar, S.; Prabahar, K.J.; Himabindu, G. Dual Analyte Determination and Validation of Trace Levels Methanesulfonic Acid and Trifluroacetic Acid in Saxagliptin Drug Substance using Ion Chromatographic Technique. Der Chem. Sin., 2017, 8(2), 273-281.
[80]
Chhabdal, P.; Balaji, M.; Srinivasarao, V.; Ramkrishna, K.; Apparao, K.M. A validated RP-HPLC method development for determination of Saxagliptin in presence of degradation impurities. Int. J. Res. Develop. Pharm. Life Sci., 2022. [Epub ahead of print]
[81]
Srividya, S.; Swetha, E.; Veeresham, C. Development and Validation of a High Performance Thin Layer Chromatographic Method for Quantitative Analysis of Saxagliptin. Am. J. Anal. Chem., 2015, 6(10), 797-806.
[http://dx.doi.org/10.4236/ajac.2015.610076]
[82]
Ghode, P.D.; Baradkar, S.S.; Sayare, A.S.; Pachauri, A.D.; Khandelwal, K.R. Stability Indicating HPTLC Method Development and Validation for the Estimation of Saxagliptin in Bulk and its Dosage Form. J. Pharmaceut. Sci. Res., 2019, 11(7), 2485-2489.
[83]
Rode, V.P.; Thorat, S.G.; Tajne, M.R. A validated stability-indicating high performance thin layer chromatographic method for the analysis of saxagliptin in bulk drug and tablet formulation. J. Chem. Pharm. Res., 2017, 5, 323-328.
[84]
Deshpande, S. v; Roy, MA.; Daswadkar, SC. Development and Validation of UV Spectrophotometric method for estimation of Saxagliptin in bulk and Pharmaceutical dosage form. Int. J. Pharmaceut. Drug Anal., 2016, 4(1), 30-34.
[85]
Narsing Koli, S.; Venkatrao Belvotagi, A.; Pritishkumar Mudke, R.; Ashok Patil, S. UV Spectrophotometric Method Development and Validation for Estimation of Saxagliptin in API and in Pharmaceutical Dosage Form. IJPPR, 2019, 14, 166-179.
[86]
Game, D.; Bopudi, N. Degradation study of dapagliflozin in API by spectroscopic method. Int. J. Pharmaceut. Drug Anal., 2018, 6(2), 84-88.
[87]
Shinde, B.S.; Kalshetti, M.S.; Kokane, A.P. UV Spectrophotometric method development and validation for estimation of Saxagliptin in API and Pharmaceutical dosage form. Int. J. Curr. Pharm. Res., 2020, 12(5), 63-66.
[http://dx.doi.org/10.22159/ijcpr.2020v12i5.39768]
[88]
Joshi, D.; Singh, B.; Rautela, A.; Semwal, N.; Pharmaceu Sci, G.J. Analytical Method Development and Validation of UV-Visible Spectrophotometric Method for the Estimation of Saxagliptin in Gastric Medium. India Glob. J. Pharmaceut. Sci., 2021, 8, 555735.
[89]
Nachaka, S.K.; Nowduri, A.; Boju, S.; Rao Battula, V. Development and validation of TEMPO content in Saxagliptin by Gas chromatography. Int. J. Adv. Pharm. Biol. Chem., 2017, 6(1), 37-45.
[90]
Upadhyay, N.K.; Rathore, C.; Sapra, S.; Negi, P. Novel RP-HPLC method development and validation for the simultaneous estimation of saxagliptin and glimepiride. Int. J. Appl. Pharmaceut., 2018, 10(3), 151-156.
[91]
Sarada, B.; Narendra Kumar Reddy, K.; Pragati Kumar, B.; Kumar Reddy, D. Method development and validation of Pioglitazone and Saxagliptin by RP-HPLC. Indian J. Res. Pharm. Biotechnol., 2017, 5(1), 44-46.
[92]
Moneeb, M.S. Spectrophotometric and spectrofluorimetric methods for the determination of saxagliptin and vildagliptin in bulk and pharmaceutical preparations. Bull. Fac. Pharm. Cairo Univ., 2013, 51(2), 139-150.
[http://dx.doi.org/10.1016/j.bfopcu.2013.03.003]
[93]
Sawant, R.L.; Mhaske, S.M. Analytical method development for simultaneous estimation of Saxaglliptin and Methyldopa. Asian J. Pharmaceut. Res., 2014, 4(3), 134-140.
[94]
Patel, K.J.; Chaudhary, A.B.; Bhadani, S.M.; Raval Ruchi, J. STability indicating rp-hplc method development and validation for estimation of dapagliflozin and metformIN HCl. World J. Pharm. Pharm. Sci., 2017, 6(9), 796-809.
[http://dx.doi.org/10.20959/wjpps20179-9638]
[95]
Patel, N.S.; Patel, B.H. Development and Validation of Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Dapagliflozin Propanediol and Metformin Hydrochloride in Tablet Dosage Form. Int. J. Pharm. Sci. Drug Res., 2020, 2020, 660-667.
[http://dx.doi.org/10.25004/IJPSDR.2020.120609]
[96]
Dighe, N.S.; Varade, P.R.; Shinde, G.S.; Rao, P.S. Quantitative estimation and validation of dapagliflozin and metformin hydrochloride in pharmaceutical dosage form by RP-HPLC. Asian J. Res. Chem, 2019, 12(3), 136.
[http://dx.doi.org/10.5958/0974-4150.2019.00028.2]
[97]
Shyamala, N.B.; Kavitha, M.; Sharma, J.V.C. Validated RP HPLC method for simulatenous estimation of Metfomin Hydrochloride and Dapagliflozin in tablet dosage form. Am. J. Biol. Pharmaceut. Res., 2015, 2(2), 109-113.
[98]
Padmaja, N.; Veerabhadram, G. Enhancing productive capabilities through intra-regional trade and cross-border investments in Southern Africa. J. Afrikana, 2017, 2, 409-425.
[99]
Lakshmi, K.P.; Satya, N.; Rama Krishna, V.; Hari, Babu B. Development and validation of stability indicating reverse Phase high performance liquid chromatography method with Photodiode array detection for the simultaneous estimation of hypoglycemic agents. Dapagliflozin and Metformin. Int. J. Pharm. Biol. Sci., 2017, 3, 8.
[100]
Yunoos, M.; Sankar, G. A validated stability indicating high performance liquid chromatographic method for simulataneous determination of Metfomin HCl and Dapagliflozin in bulk drug and tablet dosage form. Asian J. Pharm. Clin. Res., 2015, 8(3), 320-326.
[101]
Kotecha, N. Patel Jayvadan. Method Development and Validation of A Stability Indicating Reversed Phase Liquid Chromatographic Method for the Simultaneous Estimation of Metformin and Dapagliflozin in Presence of their Degradation Products. Int. J. Pharm. Sci. Rev. Res., 2019, 56(2), 1-6.
[102]
Abdel-Gawad, S.A.; Malik, A.; Al-Tamimi, S.; Adam, E.H.K. Chromatographic Simultaneous quantification of Dapagliflozin and Metformin Hydrochloride in presance of their degradation products. Int. J. Biol. Pharm. Allied Sci., 2017, 6(10), 2007-2021.
[103]
Jani, B.R. Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. J. Bioequiv., 2015, 1, 1-8.
[104]
Harde, M.; Lakade, S.; Gite, V.; Chopade, V.; Khomne, A. Ultraviolet Spectrophotometric method for simultaneous estimation of Dapagliflozin Propanediol and Metformin Hydrochloride. Int. Res. J. Pharm., 2019, 10(4), 90-94.
[105]
Bhavyasri, K. Method Development, Validation and Stress Studies of Dapagliflozin and Metformin Hydrochloride Using Ultraviolet-Visible Spectroscopy in Bulk and Combined Pharmaceutical Formulations. Biosci. Biotechnol. Res. Commun., 2020, 13(4), 1986-1992.
[http://dx.doi.org/10.21786/bbrc/13.4/53]
[106]
Sriram, N. Method development and validation for the simultaneous estimation of saxagliptin and metformin in tablet dosage form By RP-HPLC method. IJPAR, 2018, 3(4), 363-369.
[107]
Gurav, S.B.; Manish, N. Development and validation of novel stability-indicating LC method for the determination of saxagliptin and metformin. Indian J. Pharmaceut. Edu. Res., 2020, 54(2s), s350-s357.
[http://dx.doi.org/10.5530/ijper.54.2s.93]
[108]
Prasanna, R-H.A.; Priyanka, K. Method development and validation of simultaneous determination of Metformin and Saxagliptin in Pharmaceutical dosage form by RP HPLC. Int. J. Pharm. Chem. Biol. Sci., 2015, 5(1), 381-387.
[109]
Bangaruthalli, J.; Swathi, J.; Kusumpriya, N.; Hemalatha, U.; Sailaja Kumari, R. Method development and validation for simultaneous determination of Metformin and Saxagliptin by RP HPLC. Int. J. Sci. Develop. Res., 2019, 4(1), 381-387.
[110]
Nyola, N.; Jeyabalan, G. Simultaneous estimation of Saxagliptin Hydrochloride and Metformin Hydrochloride in active pharmaceutical ingrident by RP HPLC. AJPRHC, 4(3), 70-7.
[111]
Prasad, P.B.N.; Satyanaryana, K.; Krishnamohan, G. Development and validation of a method for simultaneous determination of metformin and saxagliptin in a formulation by RP-HPLC. Am. J. Anal. Chem., 2015, 6(11), 841-850.
[http://dx.doi.org/10.4236/ajac.2015.611080]
[112]
Pravin Cumar, R.; Vasudevan, M. Deecaraman. A validated RP HPLC method for simultaneous estimation of Metformin and Saxagliptin in tablets. Rasayan J. Chem., 2012, 5(2), 137-141.
[113]
Rohini, S.; Nagaraju, K. Analytical method development and validation for the estimation of Saxagliptin and Metformin by RP HPLC method. Int. J. Adv. Res. Develop, 2018, 3(10), V3I10-1138.
[114]
Barge, V.U.; Chaudhari, F.M.; Gaikwad, R.B.; Kande, T.R. Development and validation of analytical method for simultaneous estimation of Saxagliptin and Metformin HCl by using RP HPLC method. Int. Res. J. Pharm., 2018, 9(6), 142-146.
[http://dx.doi.org/10.7897/2230-8407.096106]
[115]
Merey, H.A.; Ramadan, N.K.; Diab, S.S.; Moustafa, A.A. Chromatographic methods for the simultaneous determination of binary mixture of Saxagliptin HCl and Metformin HCl. Bull. Fac. Pharm. Cairo Univ., 2017, 55(2), 311-317.
[http://dx.doi.org/10.1016/j.bfopcu.2017.04.002]
[116]
Begum, A.; Ajitha, A.; Uma Maheshwar Rao, V. Development and validation of stability indicating RP HPLC method for Saxagliptin and Metformin in tablet dosage form. Int. J. Pharm., 2014, 4(4), 271-279.
[117]
Sheikh, I.A.; Charde, M.; Mittal, A. Application of validated high-performance liquid chromatography method for degradation study of saxagliptin and metformin HCl. Int. J. Pharm. Biol. Arch., 2018, 9, 67-72.
[118]
Yunoos, M.; Gowri Sankar, D. Stability indicating quantitative RP-HPLC method development and validation for simultaneous determination of metformin hydrochloride and saxagliptin in bulk and combined tablet dosage form. J. Chem. Pharm. Res., 2015, 7(4), 346-355.
[119]
Bhagavanji, N. usein Reddy M, Kiranmayi AP. Development and Validation of stability indicating Liquid chromatographic method for the simultaneous estimation of Metformin and Saxagliptin in combined dosage form. Int. Res. J. Pharm. Appl. Sci., 2013, 3(5), 37-42.
[120]
Kumar, S.N. A validated high performance liquid chromatography method for the determination of Saxagliptin and metformin in bulk and pharmaceutical dosage form, a stability indicating study. IOSR J. Pharm. Biol. Sci., 11(6), 92-100.
[121]
Caglar, S. A validated high performance liquid chromatography method for the determination of Saxagliptin and Metformin in Bulk, a Stability Indicating Study. J. Anal. Bioanal. Tech., 2014, S14, 2012.
[http://dx.doi.org/10.4172/2155-9872.S12-010]
[122]
Jyothi, D.; Tresa, J.; Krupakar, P.; Sandhya, M. Development of UV spectroscopic method for estimation and validation of Saxagliptin and Metformin Hydrochloride by absorbance ratio method. J. Glob. Trends Pharm. Sci., 2018, 9(1), 4782-4786.
[123]
Cholke, P.; Shirsath, M.; Temak, Y.; Kagde, A.; Lagad, R. Development and validation of UV-Visible spectroscopy method for simultaneous estimation of Saxagliptin hydrochloride and metformin hydrochloride in tablet dosage form. Int. J. Res. Pharm. Sci., 2018, 3(4), 19-23.
[124]
Fernandes, V.; Subrahmanyam, E.V.S.; Shabaraya, A.R. Method development and validation for determination of Metformin Hydrochloride and Saxagliptin in bulk and marketed preparation. Int. J. Pharm. Chem. Pharmaceut. Anal., 2018, 5(3), 1-11.
[125]
Manasa, M.; Aanandhi, V.M. Stability indicating simultaneous method development and validation of dapagliflozin and saxagliptin by RP-HPLC. Res. J. Pharm. Technol., 2021, 14(2), 1045-1049.
[http://dx.doi.org/10.5958/0974-360X.2021.00187.6]
[126]
Boggula, N.; Shanmuga Pandiyan, P. Development and validation of RP HPLC method for the simulataneous estimation of Dapagliflozin and Saxagliptin in bulk and pharmaceutical dosage forms. Int. J. Pharm. Sci. Res., 2021, 12(1), 314-320.
[http://dx.doi.org/10.13040/IJPSR.0975-8232.12]
[127]
Tabassum, S.; Sathishkumar, M.; Mallik, A.; Jyothi, N. Method development and validation of Dapagliflozin and Saxagliptin by RP HPLC. EPRA Int. J. Res. Develop. (IJRD), 2021, 6(9), 134-143.
[http://dx.doi.org/10.36713/epra8448]
[128]
Rama Rao, B.; Rao, V.V.; Venkateswarlu, B.S. RP-HPLC method for simultaneous estimation of dapagliflozin and saxagliptin in bulk samples. J. Pharm. Sci. Res., 2019, 11(1), 254-257.
[129]
Sivagami, B.; Padmaja, B.R.; Babu, M.N. A highly validated RP-HPLC method development for the simultaneous estimation of dapagliflozin and saxagliptin in tablet dosage forms. Int. J. Pharm. Sci. Drug Res., 2018, 10(5), 10.
[http://dx.doi.org/10.25004/IJPSDR.2018.100503]
[130]
Gampa, V.K.; Thirupathi, K. Analytical method development and validation for the simultaneous estimation of saxagliptin and dapagliflozin in combined dosage form by Using RP-HPLC; Pharma Research Library: London, 2018.
[131]
Godge, R.K.; Shinde, G.S.; Joshi, S. Simultaneous estimation and validation of dapagliflozin and saxagliptin in bulk drug and dosage form by RP-HPLC. Res. J. Sci. Technol., 2019, 11(1), 59.
[http://dx.doi.org/10.5958/2349-2988.2019.00008.1]
[132]
Patel, P.D.; Pandya, S.S. Validated RP-HPLC method for simultaneous estimation of dapagliflozin and saxagliptin hydrochloride in tablet dosage form. IJPRS, 2018, 7(1), 9-15.
[133]
More, S.S.; Sonawane, S.S.; Chhajed, S.S.; Kshirsagar, S.J. Development and validation of RP-HPLC method for simultaneous estimation of saxagliptin and dapagliflozin in tablets. Asian J. Pharm. Technol., 2018, 8(3), 145.
[http://dx.doi.org/10.5958/2231-5713.2018.00023.5]
[134]
Madhavi, S.; Prameela Rani, A. Development and validation of a method for simultaneous determination of Dapagliflozin and Saxagliptin in a formulation by RP HPLC. World J. Pharm. Res., 2017, 6(12), 904-916.
[135]
Kommineni, V.; Chowdary, K.P.R.; Prasad, S.V.U.M. Formulation of Dapagliflozin and Saxagliptin tablets and in vitro evaluation by RP HPLC method. Asian J. Pharmaceut. Anal., 2019, 9(2), 93.
[http://dx.doi.org/10.5958/2231-5675.2019.00018.8]
[136]
Gundala, A.; Prasad, K.V.S.R.G.; Koganti, B. Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form. Braz. J. Pharm. Sci., 2019, 55, e18129.
[http://dx.doi.org/10.1590/s2175-97902019000218129]
[137]
Chowdary, K.P.R. Development of a new stability indicating RP HPLC method for simultaneous estimation of Saxagliptin and Dapagliflozin and it’s Validation as per ICH guidelines. IAJPS, 2017, 4(9), 2920-2932.
[138]
Singh, N.; Bansal, P.; Maithani, M.; Chauhan, Y. Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination. New J. Chem., 2018, 42(4), 2459-2466.
[http://dx.doi.org/10.1039/C7NJ04260D]
[139]
Pharma, D.; Rsch, P.; Krs, P.; Reddy Mallu, U. A study of new method development, validation and forced degradation for simultaneous analysis of dapagliflozin and saxagliptin in pharmaceutical dosage form by HPLC method. Der Pharma Chem., 2017, 9(20), 96-103.
[140]
Prathap, B.; Haribaskar, V. Stability Indicating RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Pharmaceutical Dosage Form; Pharma Research Library: London, 2018.
[141]
Illendula, S.; Kumar, S. Stability Indicating Method Development And Validation And Simultanious Estimation Of Dapagliflozin And Saxagliptin In Pharmaceutical Dosage Form. Indo Am. J. P. Sci., 2019, 7(6), e5384.
[142]
Sarath, N.; Sheshagiri Rao, V.L.N. A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in Combined Tablet Dosage Forms. Pharmaceut. Anal. Quality Assur., 2017, 4, 1-11.
[143]
Suthar, N.; Marvaniya, V.; Patni, P. Stability indicating method development and validation for the simultaneous estimation of Dapagliflozin and Saxagliptin in synthetic mixture by HPLC. Int. J. Pharma Sci., 2018, 9(2), 112-128.
[144]
Deepan, T.; Dhanaraju, M.D. Stability indicating HPLC method for the simultaneous determination of dapagliflozin and saxagliptin in bulk and tablet dosage form. Curr. Issues Pharm. Med. Sci., 2018, 31(1), 39-43.
[http://dx.doi.org/10.1515/cipms-2018-0009]
[145]
Lotfy, H.M.; Mohamed, D.; Elshahed, M.S. Novel univariate spectrophotometric determination of the recently released solid dosage form comprising dapagliflozin and saxagliptin via factorized response spectra: Assessment of the average content and dosage unit uniformity of tablets. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2019, 222, 117120.
[http://dx.doi.org/10.1016/j.saa.2019.05.025] [PMID: 31252262]
[146]
Laxmna, M. P Estimation of Saxagliptin hydrochloride and Dapagliflozin propendiol monohydrate in combined dosage form. JIAPS, 2018, 3(2), 1-7.
[147]
Ahmad, S.; Usman, R.M.; Shaikh, T.; Akhtar, R. Development and validation of uv spectrophotometric method for estimation of saxagliptin and dapagliflozin in bulk dosage form. Int. J. Pharm. Sci. Res., 2021, 12(4), 2185-2192.
[http://dx.doi.org/10.13040/IJPSR.0975-8232.12]
[148]
Singh Bhadauria, R.; Agarwal, V. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in marketed formulation. J. Drug Deliv. Ther., 2019, 9, 1160-1164.
[149]
Vankalapati, K.R.; Alegete, P.; Boodida, S. Stability indicating HPLC method development and validation for simultaneous estimation of metformin, dapagliflozin, and saxagliptin in bulk drug and pharmaceutical dosage form. Biomed. Chromatogr., 2022, 36(7), e5384.
[http://dx.doi.org/10.1002/bmc.5384] [PMID: 35434817]
[150]
Abdelrahman, A.E.; Maher, H.M.; Alzoman, N.Z. HPTLC method for the determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceuticals. Curr. Anal. Chem., 2020, 16(5), 609-619.
[151]
Maher, H.M.; Abdelrahman, A.E.; Alzoman, N.Z.; Aljohar, H.I. Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets. J. Liq. Chromatogr. Relat. Technol., 2019, 42(5-6), 161-171.
[http://dx.doi.org/10.1080/10826076.2019.1590208]
[152]
Ubaid, M.; Ahmad, M.; Khan, A.; Murtaza, G. Development, validation and application of HPLC method for metformin in rabbit plasma. Curr. Pharm. Anal., 2019, 15(6), 574-579.
[153]
Jagadeesh, B.; Bharathi, D.V.; Pankaj, C.; Narayana, V.S.; Venkateswarulu, V. Development and validation of highly selective and robust method for simultaneous estimation of pioglitazone, hydroxypioglitazone and metformin in human plasma by LC–MS/MS: Application to a pharmacokinetic study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2013, 930, 136-145.
[http://dx.doi.org/10.1016/j.jchromb.2013.04.024] [PMID: 23732843]
[154]
Shah, P.A.; Shrivastav, P.S. Ion-pair solid phase extraction for the simultaneous separation and quantitation of metformin and canagliflozin in human plasma by LC-MS/MS. Microchem. J., 2018, 143, 181-189.
[http://dx.doi.org/10.1016/j.microc.2018.08.005]
[155]
Oertel, R.; Baldauf, J.; Rossmann, J. Development and validation of a hydrophilic interaction liquid chromatography-tandem mass spectrometry method for the quantification of the antidiabetic drug metformin and six others pharmaceuticals in wastewater. J. Chromatogr. A, 2018, 1556, 73-80.
[http://dx.doi.org/10.1016/j.chroma.2018.04.068] [PMID: 29748091]
[156]
Govender, K.; Adamson, J.H.; Owira, P. The development and validation of a LC-MS/MS method for the quantitation of metformin, rifampicin and isoniazid in rat plasma using HILIC chromatography. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2018, 1095, 127-137.
[http://dx.doi.org/10.1016/j.jchromb.2018.07.041] [PMID: 30077092]
[157]
AbuRuz, S.; Millership, J.; McElnay, J. The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2005, 817(2), 277-286.
[http://dx.doi.org/10.1016/j.jchromb.2004.12.018] [PMID: 15686996]
[158]
Abbas Moussa, B.; Mahrouse, M.A.; Fawzy, M.G. A validated LC-MS/MS method for simultaneous determination of linagliptin and metformin in spiked human plasma coupled with solid phase extraction: Application to a pharmacokinetic study in healthy volunteers. J. Pharm. Biomed. Anal., 2019, 163, 153-161.
[http://dx.doi.org/10.1016/j.jpba.2018.09.052] [PMID: 30312887]
[159]
Porwal, P.K.; Talele, G.S. Development of validated HPLC-UV method for simultaneous determination of Metformin, Amlodipine, Glibenclamide and Atorvastatin in human plasma and application to protein binding studies. Bull. Fac. Pharm. Cairo Univ., 2017, 55(1), 129-139.
[http://dx.doi.org/10.1016/j.bfopcu.2016.10.002]
[160]
Subbareddy, P.; Divakar, T.E. Bio-analytical Development and Validation of RP-HPLC Liquid Method for Quantification of Dapagliflozin Propanediol in Spiked Human Plasma. Asian J. Org. Med. Chem., 2019, 4(1), 28-31.
[http://dx.doi.org/10.14233/ajomc.2019.AJOMC-P167]
[161]
Kazi, M.; Alqahtani, A.A.; Alsaadi, B.S.; Alkholief, M.; Alanazi, F.K. UHPLC method development for determining sitagliptin and dapagliflozin in lipid-based self-nanoemulsifying systems as combined dose in commercial products and its application to pharmacokinetic study of dapagliflozin in rats. Pharm. Chem. J., 2019, 53(1), 79-87.
[http://dx.doi.org/10.1007/s11094-019-01959-4]
[162]
Kumar, S.K. Bioanalytical method development and validation of Saxagliptin in human plasma by RP HPLC method. Pharmacophore, 2014, 5(2), 202-218.
[163]
Gao, J.; Yuan, Y.; Lu, Y.; Yao, M. Development of a rapid UPLC-MS/MS method for quantification of saxagliptin in rat plasma and application to pharmacokinetic study. Biomed. Chromatogr., 2012, 26(12), 1482-1487.
[http://dx.doi.org/10.1002/bmc.2720] [PMID: 22334441]
[164]
Batta, N.; Pilli, N.R.; Derangula, V.R.; Vurimindi, H.B.; Damaramadugu, R.; Yejella, R.P. A rapid and sensitive LC-MS/MS assay for the determination of saxagliptin and its active metabolite 5-hydroxy saxagliptin in human plasma and its application to a pharmacokinetic study. Drug Res. (Stuttg.), 2015, 65(3), 133-140.
[PMID: 24941084]
[165]
Shah, P.A.; Shah, J.V.; Sanyal, M. Shrivastav, PS. LC–MS/MS analysis of metformin, saxagliptin and 5-hydroxy saxagliptin in human plasma and its pharmacokinetic study with a fixed-dose formulation in healthy Indian subjects. Biomed. Chromatogr., 2017, 31(3), e3809.
[166]
Donepudi, S.; Achanta, S. Simultaneous estimation of saxagliptin and dapagliflozin in human plasma by validated high performance liquid chromatography - Ultraviolet method. Turkish J. Pharm. Sci., 2019, 16(2), 227-233.
[http://dx.doi.org/10.4274/tjps.galenos.2018.46547] [PMID: 32454718]
[167]
Goday, S.; Shaik, A.R.; Avula, P. Development and validation of a lc-esi-ms/ms based bioanalytical method for dapagliflozin and saxagliptin in human plasma. IJPER, 2018, 52(4s), S277-S286.
[http://dx.doi.org/10.5530/ijper.52.4s.108]
[168]
Raveendra, G.B.; Kumar, R.A.; Shaheen, S.D.; Greeshma, A. A novel stability-indicating method for the simultaneous estimation of saxagliptin and dapagliflozin in rat serum by using UV spectroscopy. Pharm. Anal. Acta, 2018, 9(3), 1000579.
[http://dx.doi.org/10.4172/2153-2435.1000579]
[169]
El-Zaher, A.A.; Hashem, H.A.; Elkady, E.F.; Allam, M.A. A validated LC-MS/MS bioanalytical method for the simultaneous determination of dapagliflozin or saxagliptin with metformin in human plasma. Microchem. J., 2019, 149, 104017.
[http://dx.doi.org/10.1016/j.microc.2019.104017]
[170]
Gumieniczek, A.; Berecka, A. Analytical tools for determination of new oral antidiabetic drugs, glitazones, gliptins, gliflozins and glinides, in bulk materials, pharmaceuticals and biological samples. Open Chem., 2016, 14(1), 215-242.
[http://dx.doi.org/10.1515/chem-2016-0023]
[171]
Eswarudu, M.M.; Aswini, R.; Srinivasa Babu, P. a review on analytical methods for estimation of Dapagliflozin and saxagliptin in bulk and in pharmaceutical dosage forms. Int. J. Res. Pharm. Chem., 2018, 8(3), 460-468.