BIOANALYTICAL METHOD FOR ESTIMATION OF TERIFLUNOMIDEIN HUMAN PLASMA

Abstract

Objective: Teriflunomide is used for the treatment of multiple sclerosis and is available in 7mg and 14mg tablets. This study aimed to develop and validatea simple and economical HPTLC method for the estimation of Teriflunomide in human plasma. Methods: HPTLC method was developed using toluene: ethyl acetate: acetic acid as the mobile phase and the stationary phase was a TLC plate precoated with silica gel 60 F254. The detection wavelength set was 294nm. The sample preparation involved a simple protein precipitation technique with Acetonitrile as a protein precipitating agent, the internal standard selected was Rilpivirine.The validationwas carried out as per bio-analytical method guidelines. Results: The Rf value for Teriflunomide was found to be 0.46±0.04. The linearity range was observed from 10-60 µg/ml with a regression coefficient value of 0.9819. The developed method was validated for various parameters like specificity, linearity, accuracy, precision, recovery, and stability. Conclusion: The developed method is simple, specific, accurate, and economical for the estimation of Teriflunomide in human plasma.