A NOVEL RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

In the present work, a rapid, specific, accurate and precise Reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Dapagliflozin and Saxagliptin in bulk and pharmaceutical dosage form. Successful chromatographic separation of Dapagliflozin and Saxagliptin was carried out with Inertsil-ODS, C₁₈ column (250 × 4.6 mm; 5 μm) with mobile phase consisted of a mixture of Methanol and Potassium dihyrogen phosphate buffer in the ratio of 45:55 v/v delivered at a flow rate of 1.0 ml/min. The eluents are monitored by PDA detector and peaks values were measured at 210 nm. The retention times for Dapagliflozin and Saxagliptin were 4.707 min and 6.684 min respectively. The present analytical method was validated according to ICH guidelines (ICH, Q2 R1). The linearity study of Dapagliflozin and Saxagliptin was found in the concentration range of 20-70 μg/ml and 20-70 μg/ml respectively and coefficient of variance was 0.999 for both drugs. % recovery was found to be 100.37% and 100.16% for Dapagliflozin and Saxagliptin respectively. LOD was 0.109 μg/ml and 0.58 μg/ml and LOQ was 0.332 μg/ml and 1.77 μg/ml for Dapagliflozin and Saxagliptin respectively. It inferred that the developed method was successfully applied for the simultaneous estimation of Dapagliflozin and Saxagliptin in bulk and its commercial pharmaceutical dosage forms and could be used for the routine analysis of the studied drugs in quality control laboratories.