Analytical Method Development & Validation for Simultaneous Estimation of Saxagliptin & Metformin in Combined Pharmaceutical Dosage Form By RP-HPLC

A rapid and precise reverse-phase high-performance liquid chromatographic method has been developed for the validation of Metformin and Saxagliptin, in their pure form as well as in tablet dosage form. Chromatography was carried out on an X terra C18 (4.6 x 150mm, 5µm) column using a mixture of ACN, Methanol, and Water (35:50:15 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 250nm. The method produces linear responses in the concentration range of 25-125ppm of Metformin and 10-50ppm of Saxagliptin. The method precision for the determination of assay was below 2.0 %RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.