DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR THE ANALYSIS OF TOLPERISONE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, sensitive, rapid and precise high performance thin layer chromatographic method has been developed and validated for the estimation of Tolperisone hydrochloride in bulk and pharmaceutical dosage form. The stationary phase used was silica gel precoated aluminum plate 60F₂₅₄ plates. The mobile phase used was a mixture of chloroform:acetone:toluene (6:2:2, v/v/v). The detection of spots was carried out at 265 nm. The method was validated in terms of specificity, linearity, precision and accuracy. The calibration curve was found to be linear between 50-600 ng/band. The developed method was subjected for forced degradation studies like acid, alkali, peroxide and thermal stress conditions were performed as per ICH guidelines. The proposed method was suitable for routine quality control analysis of Tolperisone hydrochloride in bulk and pharmaceutical formulation.