Development and Validation of Stability Indicating Rp-HPLC Method for the Simultaneous Estimation of Epalrestat and Pregabalin in Tablet Dosage Forms

Abstract

A simple, Accurate, precise method was developed and validated for the simultaneous estimation of Epalrestat and Pregabalin in Tablet dosage forms. Chromatogram was run through C8 (250 x 4.6 mm, 5µ) Column. Mobile phase contains Potassium Dihydrogen Phosphate Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. The pH was adjusted to 5.4 with Orthophosphoric acid. Temperature was maintained at 25°C. Optimized wavelength selected was 274 nm. Retention time of Epalrestat and Pregabalin were found to be 2.373 min and 2.967 min. % Relative Standard Deviation of the Epalrestat and Pregabalin were found to be 0.1and 0.3 respectively. % Recovery was obtained as 99.85% and 99.42% for Epalrestat and Pregabalin respectively. Limit of Detection, Limit of Quantification values obtained from regression equations of Epalrestat and Pregabalin were 0.24, 0.73 and 0.02, 0.07 respectively. Regression equation of Epalrestat is y = 26994x + 13337, and y = 24913x + 7779 of Pregabalin. Retention time decreased so that the run time decreased. So the method developed was simple and economical that can be adopted in regular Quality control test in Industries.