Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF SITAGLIPTIN AND METFORMIN USING REVERSE PHASE HPLC METHOD IN BULK AND TABLET DOSAGE FORM

R. Vani*, Dr..B.Vijaya Kumer, G. Krishna Mohan

ABSTRACT

A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the simultaneous estimation of Sitagliptin and Metformin in bulk and pharmaceutical dosage form using C18 column (Waters, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of 0.1 M Dipotassium Phosphate buffer (pH 7) and acetonitrile in the ratio of 70:30 v/v. The detection was carried out at 223 nm for Sitagliptin and 316 nm for Metformin. The method was linear over the concentration range for Sitagliptin 100-300 μg/ml and for Metformin 200-600 μg/ml. The recoveries of Sitagliptin and Metformin were found to be 100.27 and 100.73% respectively. The validation of method was carried out utilizing ICHguidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.

Keywords: Sitagliptin, Metformin, reverse phase HPLC, validation.