Abstract
Background: Recently, a combination prescription with the main ingredients
sitagliptin and dapagliflozin as dipeptidyl peptidase-4 andsodium–glucose cotransporter-2
inhibitors, respectively, for the treatment of type 2 diabetes has widely been issued in hospitals.
However, the development of double-layered tablets requires simultaneous quantitative
dissolution tests that are significantly efficient and cost-effective.
Objective: Individual analysis of the two active pharmaceutical ingredients (APIs) incurs
more than twice the time and cost. Consequently, this study aimed to develop a dissolution
analysis method that simultaneously quantifies the APIs dapagliflozin and sitagliptin in multi-
layered tablets. This simultaneous quantitative dissolution analysis can dramatically reduce
analysis time and cost.
Methods: For reversed-phase high-performance liquid chromatography (RP-HPLC) analysis
using ultraviolet detection, a Zorbax C18 column (4.6 × 150 mm, 5 μm) was used, and the
flow rate was 1.5 mL/min, injection amount 20 μL, and maximum absorption wavelength
set to 205 nm. Additionally, the analysis time was set to 1.5 times the retention time of
dapagliflozin.
Results: The retention times of dapagliflozin and sitagliptin were 11.57 and 2.56 min, respectively.
Further, their relative standard deviations were 0.11% and 0.05%, respectively.
Quantitative analysis using RP-HPLC confirmed no peak interference between the APIs and
excipients. Both APIs exhibited linearity at a 20–120% concentration.
Conclusion: The dissolution method developed in this study can quantify both APIs simultaneously,
thereby reducing analysis time and cost by more than 50% and increasing efficiency
in the pharmaceutical industry.
Graphical Abstract
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