Abstract

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAOHY METHOD FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN ETABONATE AND VILDAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM

Vashi Dhara* and Chaudhari Hetvi

.

Abstract

A simple, sensitive, precise, accurate and specific Chromatography RP-HPLC method has been developed and validated for estimation of Remogliflozin Etabonate and Vildagliptin in Pharmaceutical dosage form. RP-HPLC method was carried out by Isocratic mode technique on a Reversed-Phase Cosmosil C18 (250 mm × 4.6 mm, 5 μm i.d) column. Detection wavelength was at 210 nm and mobile phase Acetonitrile: Water (60:40 % v/v). The flow rate was used 1.0 ml/min. The average retention times for Remogliflozin Etabonate and Vildagliptin were 3.29 min and 5.64 min, respectively. The calibration curves were linear (r2 > 0.999) over the concentration rage 10-80 μg/ml for Remogliflozin Etabonate and 5-40 μg/ml for Vildagliptin. The r2 values was found to be 0.9997 and 0.9992 for Remogliflozin Etabonate and Vildagliptin, respectively. LOD was found to be 0.010 μg/ml and 0.029 μg/ml for Remogliflozin Etabonate and Vildagliptin, respectively and LOQ was found to be 0.031 μg/ml and 0.088 μg/ml respectively. Suitability of method for quantitative determination of compounds was confirmed by validation in accordance with the requirements of ICH guidelines.

Keywords: .