Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF TERIFLUNOMIDE IN API AND PHARMACEUTICAL DOSAGE FORM

Kinjal Patel*, Dr. Chirag Patelb, Manali Patelc and Dr. M. M. Pateld

ABSTRACT

A stability indicating RP-HPLC method was developed and subsequently validated for the estimation of Teriflunomide in API and Pharmaceutical dosage form. Separation was achieved using Agilent, Eclipse XDB C18 (150 x 4.6mm, 5μm) using ACN:0.03M Potassium Dihydrogen Phosphate (pH 7.0 adjusted with TEA) (40:60v/v)at flow rate of 0.8ml/min. The effluent is monitored at 250 nm. The retention time of was found to be 3.373min for Teriflunomide API and 3.527 min for Teriflunomide tablet. Linearity was found in the range of50 -150μg/ml (R2=0.999). Precision studies were carried out and the RSD values were less than 2. The %recoveries of Teriflunomide API and Tablet were found to be in the range of 99-100% and 98-100 %respectively. LOD and LOQ were found to be 4.94μg/ml and 14.97μg/ml respectively. Degradation study was performed using acid, alkali hydrolysis, peroxide, thermal, photolytic degradation.The results showed that Teriflunomide and the other degradation products were fully resolved and thus the proposed method is stability-indicating.

Keywords: Teriflunomide, RP-HPLC, stability indicating, HPLC method, validation.