Abstract
The scientific novelty of designed work was to develop a specific and precise stability-indicating ultra high performance liquid chromatography (UHPLC) assay method for simultaneous quantification of Sitagliptin and Metforminin extendedrelease fixed dose combinations (FDCs). 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 (90:10 % v/v) acetonitrile: potassium dihydrogen orthophosphate buffer; pH 3.0±0.2 was adjusted with 0.1 % ortho phosphoric acid (OPA), with flow rate of 0.4 mL/min of the solvent system. The analytes were supervised at 267 nm by employing photodiode array recognition. The retention times of Sitagliptin and Metformin were found to be1.903±0.01 and 1.301±0.022, respectively. The Sitagliptin and Metformin have confirmed the linearity ranges of 5- 30μg/mL, and 100-600 μg/mL respectively, with 0.9996 and 0.9996 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 analyze the Sitagliptin and Metformin with no obstruction from degradation products.
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