XÂY DỰNG VÀ THẨM ĐỊNH QUY TRÌNH ĐỊNH LƯỢNG ĐỒNG THỜI METFORMIN HYDROCLORID VÀ SAXAGLIPTIN BẰNG PHƯƠNG PHÁP SẮC KÝ LỎNG HIỆU NĂNG CAO ĐẦU DÒ UV-VIS

Abstract

Background: Metformin hydrochloride, a biguanide, and saxagliptin, a novel dipeptidyl peptidase-4 (DPP-4) inhibitor. The combination of these two active pharmaceutical ingredients in a single dosage form enhances therapeutic efficacy, reduces adverse effects, and improves patient adherence. To develop combination dosage forms containing these two compounds, it is essential to  develop and validate methods for the simultaneous determination of metformin hydrochloride and saxagliptin in tablets. Objectives: To investigate chromatographic conditions, and validate a simultaneous quantification method for metformin hydrochloride and saxagliptin using HPLC. Materials and Methods: Metformin hydrochloride and saxagliptin, and commercial fixed-dose combination tablets containing the active ingredients metformin hydrochloride and saxagliptin, were utilized. Results: Optimal chromatographic parameters were established: a Gemini C18 column (250 mm x 4.6 mm, 5 µm), mobile phase consisting of methanol:buffer (0.05N KH₂PO₄, pH 3.0):acetonitrile (20:70:10, v/v), flow rate of 1.0 mL/min, and detection wavelength 215 nm. The method was validated with recoveries ranging from 98% to 102%; linear concentration ranges of 20 – 300 µg/mL and 0.2 – 3.0 µg/mL, with regression equations of ŷ = 32341x (R² = 0.9985) and ŷ = 14129x + 2201.3 (R² = 0.9988) for metformin hydrochloride and saxagliptin, respectively. The relative standard deviations (RSD) for intra-day and inter-day precision were 1.63% – 1.56% and 1.66% – 1.35% for metformin hydrochloride and saxagliptin, respectively. Conclusion: A selective, accurate, and reliable analytical method was successfully developed for the simultaneous quantification of metformin hydrochloride and saxagliptin in fixed-dose combination tablets.