The Estimation of Epalrestat in Tablet Dosage Form by RP-HPLC.

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Epalrestat in tablet dosage form. An XTerra(R) C18 analytical column (250x4.6 mm, 5 μm particle size) with mobile phase consisting of mixture of buffer (0.03M Potassium Dihydrogen phosphate in water at pH 3.2 with ortho-phosphoric acid) and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 294 nm. The retention time was 15.9 min. The detector response was linear in the concentration of 20–120 mcg/mL. The respective linear regression equation being y= 3818.8x-3819. The limit of detection and limit of quantification was 0.005mcg/mL and 0.015mcg/mL respectively. The percentage assay of Epalrestat was 99.3%. The method was validated by determining its accuracy, precision and system suitability.

The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Epalrestat in bulk drug and in its pharmaceutical dosage form.