Development of Validated Stability Indicating HPTLC Method for the Estimation of Teriflunomide in Bulk and Tablet Dosage Form

Abstract

Background: Teriflunomide is an immunosuppressive agent. Immunosuppressive agents are drugs that inhibit or prevent activity of immune system. Teriflunomide was investigated as a medication for multiple sclerosis (MS). Various studies have reported the HPLC, UPLC, LC/MS methods for the estimation of teriflunomide. However, till date stability indicating HPTLC analysis method has not been reported for the estimation of teriflunomide in bulk and tablet dosage form. Objective: Objective of the present work was to develop and validate stability indicating high performance thin layer chromatography method for the determination of teriflunomide in bulk and tablet dosage form. Methods: Chromatography was performed on aluminium plates coated with silica gel 60F254 using toluene, methanol and acetic acid (7.5: 2.5: 0.05 v/v/v) as mobile phase. Densitometric analysis was performed at 254 nm. The method was validated with different parameters such as linearity, precision, accuracy, specificity, robustness, limit of detection (LOD) and limit of quantitation (LOQ). The RF value of teriflunomide was 0.56 ± 0.03. The method is sensitive (limit of quantification 17.83 ng/band), precise (RSD ≤ 1.34%), accurate (drug recovery 98.49–99.53 %), and linear over the range 100–600 ng/band (r2 0.998). Results: Degradation products were found in stress conditions did not interfere with the detection of teriflunomide; therefore, the proposed technique can be considered stability-indicating. Teriflunomide did not degrade under alkaline hydrolysis, thermal and photolytic conditions but showed degradation under acid hydrolysis and oxidation with about 14.5 and 13.8 % decompositions respectively. Conclusion: The developed method was satisfactorily applied for the analysis of pharmaceutical preparations and proved to be specific and accurate for quality control of the cited drugs in their tablet dosage form.