Validated RP-HPLC Method for Simultaneous Estimation of Metformin and Vildagliptin in Its Tablets

Karem Kishore Kumar Reddy, Shaik Mohammed Yusuf^*, E. Vijay Kumar, Bumireddy Pavani, E. Divya, Vummadi Sai Chandana
Department of Pharmaceutical Analysis, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, YSR Kadapa, A.P. India

A B S T R A C T
A simple, rapid, sensitive and robust reversed phase-HPLC method was developed and validated to measure simultaneously the amount of Metformin and Vildagliptin at single wavelength (258 nm) in order to assess quantification in its tablet formulation and its subsequent stability studies. An isocratic elution of filtered sample was performed on Water’s C18 column with buffered mobile phase (0.1 M Di-potassium Phosphate buffer (pH 7) and acetonitrile in the ratio of 70:30 v/v) with PDA detection at 258 nm. The linearity for concentrations between 1000 and 3000 μg/ml for metformin and 100 and 300 μg/ml for vildagliptin were established. Intra and inter-day precision were less than 2%. The limits of detection (LOD) and quantification were 1.1 and 3.6 mg/ml for metformin and 0.3 and 0.8 mg/ml for vildagliptin. The determination of the two active ingredients was not interfered by the excipients of the products. This method was satisfactorily applied to the analysis of the tablet formulations and proved to be specific and accurate for the quality control of the cited drugs in tablet dosage form.
Keywords: Metformin, Vildagliptin, Dipotassium Phosphate buffer, acetonitrile, isocratic.