Volume : 10, Issue : 03, March – 2023
13.ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TERIFLUNOMIDE TABLETS DOSAGE FORM BY RP-HPLC
Sana, Dr.K.Vanitha Prakash
A simple Reverse Phase High Performance Liquid Chromatographic method has been developed and subsequently validated for Teriflunomide tablets. The separation was carried out by using a Buffer : acetonitrile (65:35). The detection was carried out at 250nm. The column was Zorbax Eclipse XDB, C8,150 x 4.6mm, 5µl. The flow rate was selected as 1.5ml/min. The Retention time of Teriflunomide tablets was found to be 6.0. The asymmetry factor or tailing factor of Teriflunomide tablets was found to be 1.2, which indicates symmetrical nature of the peak. The number of theoretical plates of Teriflunomide tablets was found to be 7391, which indicates the efficient performance of the column. These parameters represent the specificity of the method. From the linearity studies, specified concentration levels were determined. It was observed that Teriflunomide tablets were linear in the range of 5% to 150% for the target concentration by RP-HPLC. The linearity range of Teriflunomide tablets 5% to 150% was found to obey linearity with a correlation coefficient of 0.999. The validation of the proposed method was verified by system precision and method precision by RP-HPLC. The %RSD of system suitability for Teriflunomide tablets was found to be 0.25. The validation of the proposed method was verified by recovery studies. The percentage recovery range was found to be satisfied which represent in results. The robustness studies were performed by changing the flow rate, filters and wavelength. The ruggedness study was also performed. The analytical method validation was carried out by RP-HPLC as per ICH guidelines and given below are the tables are the summary of the results.
Keywords: Teriflunomide, RP‐HPLC, Method development, Validation
Cite This Article:
Please cite this article in press Sana et al, Analytical Method Development And Validation Of Teriflunomide Tablets Dosage Form By RP-HPLC., Indo Am. J. P. Sci, 2023; 10 (03).
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1. O’Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R: A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900. [Article]
2. Tallantyre E, Evangelou N, Constantinescu CS: Spotlight on teriflunomide. Int MS J. 2008 Jun;15(2):62-8. [Article]
3. FDA Approved Drug Products: AUBAGIO (teriflunomide) tablets [Link]
4. 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.
5. 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.
6. Nadella NP, Ratnakaram VN, Srinivasu N. Quality-by-designbased 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 Relat Technol 2017;40:517-27.
7. Mehta B, Prajapat P, Gohil Y. Development and validation of stability indicating RP-HPLC method for estimation of teriflunomide in an active pharmaceutical ingredient. J Pharm Innov 2017;6:440-9.
8. 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 chromatographytandem mass spectrometry. J Chromatogr B 2010;878:2217-25.
9. 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.
10. 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.
11. 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.
12. International Conference on Harmonization, “Q2A: Text on Validation of Analytical Procedures. Federal Register 1995;60:11260–2.