STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF EPALRESTAT AND PREGABALIN IN BULK AND TABLET DOSAGE FORM

A new simple, sensitive, precise, accurate and stability indicating RP-HPLC method has been developed for the simultaneous determination of epalrestat and pregabalin in combined tablet dosage form. The chromatogram was achieved with STD Discovery column 250 x 4.6 mm, 5 mu and mobile phase containing 0.1% ortho phosphoric acid buffer and acetonitrile taken in the ratio of 45: 55 was pumped through column at a flow rate of 1 ml/min. temperature was maintained at 25 degrees C. The effluents were monitored at 244 nm by using PDA detector. The retention time of epalrestat and pregabalin were found to be 2.407 min and 3.272 min. The validation of the method was done according to the ICH guidelines for different analytical parameters. The method was found to be linear in the range of 37.5 - 225 mu g and 18.75 - 112.5 mu g/ml for epalrestat and pregabalin respectively. The assay of marketed formulation was determined and find with 99.22% and 99.07% w/v for epalrestat and pregabalin respectively. The stressed sample was analysed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compound and excipients were noticed. So the method was simple and economical that can be applied successfully for simultaneous estimation of both epalrestat and pregabalin in bulk and combined tablet formulation.