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Acta Biomedica Scientia

Volume 4, Issue 3, 2017
Mcmed International
Acta Biomedica Scientia
Issn
2348 - 215X (Print), 2348 - 2168 (Online)
Frequency
bi-annual
Email
editorabs@mcmed.us
Journal Home page
http://mcmed.us/journal/abs
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Abstract
Title
RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TERIFLUOMIDE IN TABLET DOSAGE FORM
Author
K.Dinesh Babu, D.Babu Ananth, C.N.Arul Anand Raj
Email
dinesh.dinpharmaus@gmail.com
keyword
Keywords
Abstract
The drug analysis plays an important role in the development, manufacture and therapeutic use of drugs. Standard analytical procedure for newer drugs or formulation may not be available in Pharmacopoeias; hence it is essential to develop newer analytical methods which are accurate, precise, specific, linear, simple and rapid. Hence, it is proposed to improve the existing method and to develop a new method and validate for the estimation of Terifunomide in pharmaceutical dosage form. 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 has been 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. From the linearity studies, specified concentration levels were determined. It has been 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 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.
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