NOVEL UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM
Keywords:UV spectrophotometric, Teriflunomide, Marketed formulation, ICH guideline, Sensitivity
Objective: The current work is intended towards the development of a novel, simple, and precise UV spectrophotometric method for the estimation of teriflunomide (TEF) present in the marketed formulation.
Methods: Acetonitrile was used as asolvent and the absorbance of the drug was measured at the absorbance maxima of TEF, UV 284 nm.
Results: Calibration curve plotted in concentration range 5-10 µg /ml exhibited excellent linear relationship with line equation y = 0.0858x-0.0223 and r2 value of 0.9996. The method was found to comply all the validation parameters as per the ICH guideline indicating the sensitivity of the method towards analyte.
Conclusion: The method can be used satisfactorily for the routine analysis of TEF present in marketed formulation.
2. Bruneau JM, Spinella Jaegle S, Fudali C, Woodward K, Robson PA, SautEs C, et al. Purification of human dihydro-orotate dehydrogenase and its inhibition by A77 1726, the active metabolite of leflunomide. Biochem J 1998;336:299-303.
3. O’connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, et al. A phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology 2006;66:894-900.
4. Klineova S, Krieger S. Emerging therapies in multiple sclerosis, Handbook of Relapsing-Remitting Multiple Sclerosis; 2017. p. 99–113.
5. Sobhani K, Garrett DA, Liu DP, Rainey PM. A rapid and simple high-performance liquid chromatography assay for the leflunomide metabolite, teriflunomide (A77 1726), in renal transplant recipients. Am J Clin Pathol 2010;133:454-7.
6. Schmidt A, Schwind B, Gillich M, Brune K, Hinz B. Simultaneous determination of leflunomide and its active metabolite, A77 1726, in human plasma by high-performance liquid chromatography. Biomed Chromatogr 2003;17:276-81.
7. Nadella NP, Ratnakaram VN, Srinivasu N. Quality-by-design-based development and validation of a stability-indicating UPLC method for quantification of teriflunomide in the presence of degradation products and its application to in vitro dissolution. J Liq Chromatogr R T 2017;40:517-27.
8. Mehta B, Prajapat P, Gohil Y. Development and validation of stability indicating RP-HPLC method for estimation of teriflunomide in the active pharmaceutical ingredient. Pharm Innovation 2017;6:440-9.
9. Parekh JM, Vaghela RN, Sutariya DK, Sanyal M, Yadav M, Shrivastav PS. Chromatographic separation and sensitive determination of teriflunomide, an active metabolite of leflunomide in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B 2010;878:2217-25.
10. Rakhila H, Rozek T, Hopkins A, Proudman S, Cleland L, James M, et al. Quantitation of total and free teriflunomide (A77 1726) in human plasma by LC–MS/MS. J Pharm Biomed Anal 2011; 55:325-31.
11. Rule GS, Rockwood AL, Johnson Davis KL. LC–MS/MS method for determination of teriflunomide, over a 40,000-fold dynamic range using overlapping calibrators. Ther Drug Monit 2015;37:472-8.
12. Suneetha A, Raja RK. Comparison of LC-UV and LC–MS methods for simultaneous determination of teriflunomide, dimethyl fumarate and fampridine in human plasma: application to rat pharmacokinetic study. Biomed Chromatogr 2016;30:1371-7.
13. ICH Q2A Text on Validation of analytical procedures, International Conference on Harmonization tripartite guidelines; 1994.
14. ICH Q2B Text on validation of analytical procedures: Methodology International Conference on Harmonization; 1996.