A novel analytical method for simultaneous quantification of dapagliflozin and sitagliptin by reverse phase high performance liquid chromatography

Abstract

The Reverse phase HPLC method was developed for simultaneous determination of Dapagliflozin and Sitagliptin in single analytical method. Chromatographic separation was achieved on a Hypersil BDS C18 (250mmx4.6mm, 5µm) column applying an gradient elution based on potassium phosphate monobasic buffer pH (3.0) as mobile phase A while methanol and acetonitrile in the ratio of (60:40 v/v) as a mobile phase B with gradient program Time/Mobile phase A%/Mobile phase B% is as 0 min./55/45, 3 min./55/45, 9 min./20/80, 13 min.20/80, 15 min./55/45, 20 min./55/45. Validation parameters specificity, linearity, accuracy, precision and robustness have been observed to be desirable over the concentration ranges of 50-150 µg/ml for Dapagliflozin and Sitagliptin respectively. All the variables have been studied to optimize the chromatographic conditions. The optimized approach verified through validation and confirmed to be intended purpose for the quality control of the mentioned drugs, as per ICH guidelines. For simultaneous quantification of Dapagliflozin and Sitagliptin, the developed method was found to be genuinely exact precise, accurate, linear, fast and cost effective.