A Comprehensive Stability-indicating Method for Teriflunomide: Impurity Profiling and Degradation Analysis in Tablet Formulations

Abstract

This study presents a stability-indicating method for teriflunomide, a drug administered to adults for the treatment of multiple sclerosis (MS) in its various forms, including clinically isolated syndrome, relapsing–remitting, and active secondary progressive disease. The method, which has been validated comprehensively for both impurities and the assay, plays a key role in determining teriflunomide in tablet formulations. It successfully separates two specified degradation impurities in line with the European Pharmacopeia (EP) standards. To assess the stability of teriflunomide, the method subjects it to stress conditions such as acid/base hydrolysis, oxidation, photodegradation, and thermal degradation. Using a C18 column at 30 ℃, with a mobile phase of pH 3.4 solutions and acetonitrile at 0.8 mL/min, and UV detection at 248 nm, the method ensures the resolution of degradation products from the primary teriflunomide peak. The teriflunomide peak remained pure under all stress conditions, confirming the specificity and stability-indicating nature of the method. The validation followed FDA and ICH guidelines, with results for linearity, accuracy, precision, specificity, robustness, limit of detection, limit of quantification, and system suitability all meeting established acceptance criteria.