Volume : 10, Issue : 03, March – 2023
Title:
13.ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TERIFLUNOMIDE TABLETS DOSAGE FORM BY RP-HPLC
Authors :
Sana, Dr.K.Vanitha Prakash
Abstract :
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).
Number of Downloads : 10
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