Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Leflunomide

Abstract

A new simple, specific, accurate and precise RP-HPLC method was developed for determination of Leflunomide. In the present study, stress testing of Leflunomide was carried out according to ICH guidelines Q1A (R2). Leflunomide was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Effective separation of drug and degradant was achieved was achieved on a Hypersil BDS C18 column (250mm × 4.6mm, 5.0μ particle size) under specific stress conditions using acetonitrile – 0.02M ammonium acetate buffer (60: 40, v/v) as a solvent system with a flow rate of 1.0mL/min. Quantification and linearity was achieved at 260nm over the concentration range of 5-30μg/mL for Leflunomide. The investigated method was validated as per guidelines.