Abstract

DEVELOPMENT AND VALIDATION OF A METHOD FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN A FORMULATION BY RP-UPLC

S. Madhavi* and A. Prameela Rani

ABSTRACT

In the present study, a rapid, an accurate and precise Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for simultaneous estimation of Saxagliptin and Dapagliflozin in its tablet dosage form (10mg Dapagliflozin and 5mg Saxagliptin) by selecting chromatographic parameters. The UPLC method was developed using 2.1 × 100 mm, reverse phase C18 column (Acquity UPLC ethylene bridge hybrid (BEH) C18 1.7 μm) with mobile phases containing 0.1% ortho phosphoric acid and acetonitrile (40:60) as mobile phase. Flow rate was 0.3 ml/min with PDA detection at (λmax) 254 nm and the injection volume was set at 1 μl with run time 3 min. The method was validated by using various validation parameters like accuracy, precision, linearity and robustness. These results show the method could find practical application as a quality control tool for analysis of the drug in its tablet dosage forms in pharmaceutical industries.

Keywords: Saxagliptin, Dapagliflozin, UPLC, Validation, method.