Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC

Abstract

Drug analysis is crucial in the discovery, production, and therapeutic use of pharmaceuticals. Standard analytical procedures for newer medications or formulations may not be available in Pharmacopoeias; thus, newer analytical methods that are accurate, precise, specific, linear, simple, and rapid must be developed. A rapid, simple, sensitive, precise, and cost-effective RP-UHPLC method was developed and validated for the determination of Teriflunomide Active Pharmaceutical Ingredient (API) in this study. The method involved determination of Teriflunomide by resolving on RP-UHPLC using Sunniest C18 (250mm × 4.6mm, 5μm) column, utilizing a mobile phase of ACN: Water in the ratio of 60:40 v/v. The mobile phase was delivered with an isocratic flow rate of 1.0ml/minute. Ultra violet detection was carried out at 210nm. The retention time was optimized to 4. 4 minutes. The linearity range of Teriflunomide 35 to 247µg/ml was found to obey linearity with a correlation coefficient of 0.999. The LOD and LOQ were found to be 1.61µg/ml and 4.90µg/ml respectively and precision data was found to be <2 %RSD. The percentage recovery range was found to be satisfied which is represented in the results. The robustness studies were performed by changing the flow rate and mobile phase compositions. The method was validated for system suitability, specificity, linearity, precision, accuracy, Limit of Detection, Limit of Quantification and robustness. The developed method can be applied for the quality control of commercial teriflunomide API.