Analytical Method Development and Validation for Estimation of Teriflunomide Tablet

Abstract

Stability of the pharmaceutical product is most important, so that work is carried out to develop a new, simple, precise, accurate, validated stability indicating RP-HPLC method for estimation of Teriflunomide in its tablet dosage form. In this method 0.25% v/v Trifluoroacetic acid in Water, Acetonitrile and Methanol (30:50:20 % v/v) was used as a mobile phase and Ace C18 (250*4.6, 5 µm) column was used for the separation of drug with other degraded product. The flow rate 1.5 mL/min, detection wavelength 250 nm and 25 0 C column temperature was used. The retention time for Teriflunomide was found to be 4.02 minute. The developed method meets all the acceptance criteria for the validation of analytical method as per the ICH guideline. A simple, precise, and accurate stability indicating RP-HPLC method was developed for estimation of Teriflunomide in pharmaceutical dosage form. Validation parameter proves that method is repeatable, sensitive, and selective for the analysis of Teriflunomide. Based on this evidence the method can be stated as highly economical and it is recommended for routine analysis and stability studies.