DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR THE QUANTITATIVE ESTIMATION OF SITAGLIPTIN PHOSPHATE IN BULK AND TABLET DOSAGE FORM

Abstract

A novel very rapid, sensitive, reverse phase High Performance Liquid Chromatography (RP-HPLC) technique was developed for the quantitative estimation of Sitagliptin phosphate in bulk and tablet dosage form. It was resolved by using a mobile phase of Acetonitrile and Phosphate buffer in the ratio of 60:40 v/v at a flow rate of 1.0 mL/min. using UVVisible detector at the wavelength of 263 nm for quantification. Efficient separation was achieved for Sitagliptin on used Cosmosil C18 (100 × 2.1 mm, 5μm). The retention time of Sitagliptin was 2.37 min. The calibration graphs were linear and the method showed excellent recovery for tablet dosage form. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness.