Bioequivalence Analysis of Sitagliptin/Metformin 50/500 mg Tablets Using LC-MS/MS in Human Plasma
Keywords:
Sitagliptin, Metformin, Bioequivalence, LC-MS/MS , PharmacokineticsAbstract
This study presents a comprehensive bioequivalence analysis of Sitagliptin/Metformin 50/500 mg tablets utilizing Liquid Chromatography–Mass Spectrometry (LC-MS/MS) in human plasma. The methodology adhered to stringent analytical validation standards outlined in ICH M10 and EMEA guidelines. Calibration curves were established for both analytes in the range of 0.4–60 ppm for Sitagliptin and 0.08–12 ppm for Metformin, demonstrating excellent linearity (R² > 0.995). Specificity tests confirmed no significant interference from matrix components or internal standards. The method validation encompassed critical parameters including precision, accuracy, and stability, ensuring reliability in pharmacokinetic profiling.
The study enrolled healthy volunteers under a randomized, crossover design to assess the pharmacokinetic equivalence of the test and reference formulations. Plasma concentrations were quantified over a 72-hour period, capturing key parameters such as maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC). Results demonstrated that the 90% confidence intervals for the Cmax and AUC ratios fell within the regulatory limits of 80.00% to 125.00%, establishing bioequivalence. The findings confirm the suitability of the test formulation as a therapeutic equivalent to the reference drug. This validated analytical method offers a robust framework for future bioequivalence studies involving multi-analyte pharmaceutical combinations.
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References
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