Abstract

DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF EPALRESTAT AND PREGABALIN AND METHYLCOBALAMIN IN BULK AND AS WELL AS IN PHARMACEUTICAL FORMULATION

Karishma Sivapurm* and Nanda Kumar KV

ABSTRACT

A simple, accurate, precise method was developed for the simultaneous estimation of the Methylcobalamin, Epalrestat and Pregabalin in solid dosage form. Chromatogram was run through BDS C18150x4.6mm, 5. Mobile phase containing Buffer and Acetonitrile in the ratio of 55:45 v/v was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.01N KH2PO4 buffer at pH PH adjusted to 4.0 with dil. Orthophosphoric acid solution. Temperature was maintained at 30°C. Optimized wavelength for Methylcobalamin, Epalrestat and Pregabalin was 235.0 nm. Retention time of Methylcobalamin, Epalrestat and Pregabalin were found to be 2.233 min, 2.713min and 3.673 min. %RSD of system precision for Methylcobalamin, Epalrestat and Pregabalin were and found to be 0.9, 0.3and 0.4 respectively. %RSD of method precision for Methylcobalamin, Epalrestat and Pregabalin were and found to be 0.8, 0.3 and 0.8 respectively. % recovery was obtained as 100.54%, 99.78% and 100.09% for Methylcobalamin, Epalrestat andPregabalin respectively. LOD values are obtained from regression equations of Methylcobalamin, Epalrestat andPregabalin were 0.01ppm, 0.19ppm, 0.73ppm and LOQ values are obtained from regression equations of Methylcobalamin, Epalrestat and Pregabalin were 0.02ppm, 0.59pm, 2.21ppm respectively. Regression equation of Methylcobalamin was y = 182967.x + 710.8 Epalrestate was y = 14157x + 11297 and of Pregabalin was y = 15396.x + 11063.

Keywords: Methylcobalamin.Epalrestat, Pregabalin, RP-HPLC.