Validated Stability-Indicating Assay UHPLC Method for Simultaneous Analysis of Saxagliptin and Metformin in Fixed-Dose Combinations

Abstract

A Saxagliptin (SAX) and Metformin (MET) fixed-dose combination (FDC) can improve the chances of achieving optimal glycaemic control in type 2 diabetes mellitus subjects. Accordingly, the scientific novelty of design work was to develop a specific and precise stability-indicating UHPLC assay method for simultaneous quantification of cited drugs in extended-release FDC's. The reversed-phase UHPLC resolution was analyzed with the assistance of UPLC BEH C18 (150 mm × 2.1 mm) with 1.7 µm particle size column at ambient temperature using a solvent system in a proportion of (85:15 % v/v) potassium dihydrogen orthophosphate buffer and acetonitrile, with 0.4 mL/min rate of flow of a solvent system. The analytes were supervised at 220 nm by employing photodiode array recognition. The retention times of analytes SAX and MET were 2.687 ± 0.022 min and 1.856 ± 0.03 min, respectively. The SAX and MET have confirmed the linearity ranges of 10 – 60 μg/mL and 100 – 600 μg/mL, with 0.9989 and 0.9979 determination coefficients. The UHPLC method was effectually validated concerning the accuracy, precision, sensitivity, robustness, ruggedness, selectivity, and specificity. Moreover, the anticipated UHPLC method's capability to analyzed the SAX and MET with no obstruction from degradation products.