Abstract

A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND SITAGLIPTIN IN BULK AND FORMULATION

G. Rohit Reddy*, Dr. VVS Rajendra Prasad, Dr. Alluri Ramesh, Dr. Petikam Lavudu, D. Rakesh Goud

ABSTRACT

A Simple, accurate, precise, rapid, sensitive and reproducible method has been developed and validated for the simultaneous determination of Metformin and Sitagliptin by using HPLC-Water Model No. 2690/5 series compact system consisting of Inertsil/BDS C18 (250×4.6mm, 5μ particle size) column with Methanol: Phosphate buffer (55:45) as mobile phase adjusted pH (3.5) with O-Phosphoric acid and a flow rate of 1.0ml/min and with PDA detection wavelength 260nm. The retention times for metformin and sitagliptin were 2.869 and 3.942 min respectively. The calibration plots were liner over the range of 20- 80μg/ml of the target concentration of both the drugs. The present recovery was found to be 98.0 – 101.50 was liner and precise over the same range. The method developed validated as per ICH guidelines.

Keywords: Sitagliptin, Metformin, Reverse Phase HPLC, Validation, simultaneous estimation.