Simultaneous Estimation of Saxagliptin Hydrochloride and Metformin Hydrochloride in Active Pharmaceutical Ingrident by RP-HPLC

A new simple, accurate, precise and reproducible RP - HPLC method has been developed for the simultaneous estimation of Saxagliptin and Metformin in bulk drug form using C₁₈ column (Phenomenex, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of 0.02M Potassium dihydrogen phosphate (KH ₂ PO ₄) , Acetonitrile , Methanol in the ratio of 50 : 2 5 :25 (v/v /v ) at pH 4.3 . The detection w avelength was carried out at 240 nm. The method was linear over the concentra tion range for Saxagliptin 1 0 - 5 0μg/ml and for Metformin 5 - 25μg/ml. The recoveries of Saxagliptin and Metformin were found to be 100.48and 101 . 1 % respectively. The validation of method was carried out utilizing ICH - guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.