Simultaneous Determination of Metformin and Vildagliptin in Solid Dosage Form by Stability Indicating Rp-hplc Method

A simple, precise and rapid HPLC method has been developed for the simultaneous determination of Metformin and Vildagliptin in pharmaceutical dosage form. The method was carried out using Sunfire BDS C8 column (250 mm x 4.6 mm, 5 μm) and mobile phase comprised of disodium hydrogen phosphate pH 7.0±0.05 as buffer and acetonitrile in the ratio of 60:40 v/v and degassed under ultrasonication. The flow rate was 1.0 mL/min and the effluent was monitored at 263 nm. The retention times of Metformin and Vildagliptin were 2.07 min and 3.52 min respectively. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection, limit of quantitation and by performing recovery study. Linearity was in the range of 1000.60 to 3001.80 μg/mL for Metformin and 100.20 to 300.60 μg/mL for Vildagliptin respectively. The percentage recoveries of both the drugs were ranging from 98.8 to 101.9 for Metformin hydrochloride and 98.5 to 102.1 for Vildagliptin respectively from the tablet formulation. The proposed method is suitable for the routine quality control analysis of simultaneous determination of Metformin and Vildagliptin in bulk and pharmaceutical dosage form.