A Validated Ion‐Pair Reversed‐Phase High‐Performance Liquid Chromatography for Simultaneous Quantification of Metformin Hydrochloride, Empagliflozin, and Linagliptin in the Antidiabetic Drug Combination and Dissolution Media
Abstract
The global prevalence of type 2 diabetes mellitus has prompted the development of polypill therapies to improve patient compliance, enhance therapeutic efficacy, and manage multiple pathophysiological defects. Among these, the triple combination of metformin hydrochloride (MET), empagliflozin (EMP), and linagliptin (LIN) in an extended‐release tablet formulation has gained significant clinical attention, while no validated analytical method has previously been available for their simultaneous determination in dissolution media. This study is the first to establish an ion‐pair reversed‐phase high‐performance liquid chromatography method for the simultaneous quantification of MET, EMP, and LIN in the dosage form, simulated gastric and small intestinal media (pH 1.2, 4.5, and 6.8). Separation was achieved on an XTerra C18 column (250 4.6 mm, 5 m, 40°C) with a photodiode array detector at 224 nm. Sodium dodecyl sulphate (7 mM) was used as an ion‐pairing agent in a binary gradient mobile phase of solution A (acetonitrile [ACN], triethylamine [TEA], phosphoric acid, and water, 65:0.05:0.05:35), and solution B (ACN, TEA, phosphoric acid, and water, 15:0.05:0.05:85). The procedure met the requirements for specificity, system suitability, linearity (MET 240–560 ppm,
r
2
= 0.9998; EMP 2.4–5.6 ppm,
r
2
= 0.9995; LIN 1.2–2.8 ppm,
r
2
= 0.9996), accuracy (92%–102%), relative standard deviation <2.0%, intra‐day and inter‐day precision with the recoveries from 98% to 102%, robustness with…
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