Abstract
Background: Due to lack of stringent regulations and standards from regulatory
authorities, Ayurvedic formulations available in the market are not properly standardized
and assessed for their quality. Asava and arishta are very important fermented and commonly
used dosage forms of Ayurveda. Information on the quantitative parameters of the
ayurvedic fermented preparations is very poor. These formulations contain naturally selfgenerated
alcohol that acts as the medium for extraction of active ingredients of the herbs.
Hence alcohol content becomes a point of concern as well as an important parameter for
standardization of the asava and arishta and it becomes important for manufacturers to mention
alcohol content on the label. In addition, as per ASU GMP guidelines, it is mandatory
to assess the accurate ethanol content to ensure the quality of the product. However manufacturers
used to escape to comply with the guidelines because of complexity, cost and time
consuming available methods. Hence there was a need to develop a novel method.
Objective: This study is intended to develop a simple, efficient, less time consuming, economic
and accurate gas chromatography method and estimate the ethanol content in marketed
ayurvedic formulations of asava and arishta.
Methods: The GC system (Nucon 5700 Gas Chromatograph) fitted with flame ionization
detector was used in the present study. A capillary packed column (2m length and 3.170mm
diameter) with stationary phase made up of WHP having 0.14mm in mesh size with nitrogen
carrier gas was, used and the data were acquired through Winchrom software.
Results and Discussion: The retention time for ethanol was found to be 1.53min. The correlation
coefficient (r2) of ethanol was found to be 0.9990. The ethanol content obtained by
the proposed method was found to be between 3.05% and 11.53%.
Conclusion: The study presents a simple and validated gas chromatographic method for estimation
of ethanol content in herbal formulations. The developed method was found to be
specific, accurate, precise and rugged. The method has been successfully applied for the
analysis of marketed ayurvedic formulations.
Keywords:
Ethanol content, fermented ayurvedic formulations, asava and arishta, ICH complaint method,
gas chromatography, flame ionization.
Graphical Abstract
[1]
Mishra AK, Gupta A, Gupta V, et al. Asava and arishta: An ayrvedic medicine - An overview. Int J Pharm Biol Arch 2010; 1(1): 24-30.
[2]
Rastogi S. Building bridges between ayurveda and modern science. Int J Ayurveda Res 2001; 1(1): 41-2.
[3]
Valiathan MS, Thatte U. Ayurveda: The time to experiment. Int J Ayurveda Res 2001; 1(1): 3-4.
[4]
Wadkar KA, Kondawar MS, Lokapure SG. Standardization of marketed amritarishta - A herbal formulation. Int J Pharmacol 2016; 3(9): 392-9.
[5]
Bhondave P, Burase R, Takale S, et al. Yeast consortium isolated from Woodfordia fruticosa flowers proved to be instrumental for traditional Ayurvedic fermentation. Int J Pharm Biomed Res 2013; 4(1): 37-45.
[6]
Chaudhary A, Singh N, Dalvi M, et al. A progressive review of sandhana kalpana (Biomedical fermentation): An advanced innovative dosage form of ayurveda. Ayu 2011; 32(3): 408-17.
[7]
Dahanukar SA, Kulkarni RA, Rege NN. Pharmacology of medicinal plants and natural products. Indian J Pharmacol 2000; 32: S81-S118.
[8]
Kalaiselvan V, Shah AK, Patel FB, et al. Quality assessment of different marketed brands of dasamoolarishtam, an ayurvedic formulation. Int J Ayurveda Res 2010; 1: 10-3.
[9]
Sayyad SF, Randive DS, Jagtap SM, et al. Preparation and evaluation of fermented ayurvedic formulation: Arjunarishta. Int J Appl Pharm Sci Res 2012; 2(5): 122-4.
[10]
Nandre BN, Bakliwal SR, Rane BR, et al. Traditional fermented formulations - Asava and Arishta. Int J Pharm Biol Arch 2012; 3(6): 1313-9.
[11]
Dhiman A, Sharma K, Sharma A, et al. A review on the status of quality control and standardization of herbal drugs in India. Drug Dev Ther 2016; 7: 107-12.
[12]
Ashish KS, Rajesh K, Anurag M, et al. Problems associated with clinical trials of ayurvedic medicines. Braz J Pharmacog 2010; 20(2): 276-81.
[13]
Singh RH. Exploring issues in contemporary ayurvedic education. Ayu 2015; 36(4): 361-3.
[14]
Baru RV. Challenges for regulating the private health services in India for achieving universal health care. Indian J Public Health 2013; 57: 208-11.
[15]
Bhalerao S, Munshi R, Tilve P, Kumbhar D. A survey of the labeling information provided for ayurvedic drugs marketed in India. Int J Ayurveda Res 2010; 1(4): 220-2.
[16]
Dukes GE, Kuhn JG, Evens RP. Alcohol in pharmaceutical products. Am Fam Physician 1997; 16(3): 97-103.
[17]
Dhara KV, Saurabh KB, Gurmeet SC. Method development for estimation of alcohol in ayurvedic formulations using gas chromatography. Bull Pharm Res 2012; 2(1): 34-7.
[18]
Wadher SJ, Puranik M, Yeole PG, Lakhande CS. Determination of ethanol in abhayarishta by gas chromatography. Indian J Pharm Sci 2007; 69: 152-4.
[19]
Selvan PS, Priya ES. Determination of ethanol content in ayurvedic formulations Kumaryasava and Mustakarista by gas chromatography. Indian J Pharm Sci 2015; 77(1): 120-5.
[20]
ICH guidelines. Analytical method validation (Q3) Geneva 2000.
[21]
ICH. "Validation of analytical procedures and methodology In: Proceedings of the International Conference on Harmonization. Geneva, Switzerland 2005.
Download PDF Flyer