DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR ESTIMATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM

A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for Teriflunomide In its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Teriflunomide in its Pharmaceutical Dosage Form has been developed. The separation was achieved by Cosmosil (250mm x 4.6 mm) column and Buffer (pH 4.0): Methanol (40:60) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 248 nm. Retention time of Teriflunomide was found to be 3.300 min. The method has been validated for linearity, accuracy and precision. Linearity observed for Teriflunomide 10-30 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Teriflunomide in its Combined Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in Thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form. Keywords: Teriflunomide, Stability indicating RP-HPLC Method, Validation.