Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND SITAGLIPTIN IN BULK AND DOSAGE FORM BY RP- HPLC

Pavan Kumar V.*, M. Kavitha, Sonalika Patro, Ch. Bhavya and Anupam Kanti Bag

Abstract

A simple, accurate, rapid and precise method is developed for the quantitative simultaneous determination of Metformin and Sitagliptin in combined pharmaceutical dosage form. The method was based on HPLC separation of two drugs in reverse phase mode using C18, (250 X 4.6 mm), 5μ by using Potassium Di hydrogen phosphate buffer (pH 4.0) and Methanol in the ratio of 60:40 v/v was pumped through column at a flow rate of 1.0 ml/min and detection wavelength was set at 210 nm. The retention time was 2.39 min for Metformin and 3.37 min for Sitagliptin respectively. The % RSD of Metformin and Sitagliptin were found to be 0.8 and 0.4 respectively. The % recovery was obtained as 100.43 and 100.50 for Metformin and Sitagliptin respectively. The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2), accuracy (98-102%), specificity, LOD, LOQ values in accordance with ICH guidelines. The developed method is applicable for routine quality control analysis of selected combined dosage forms.

Keywords: RP-HPLC, Metformin and Sitagliptin.