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Sci. Pharm. 2015, 83(1), 85-93; doi:10.3797/scipharm.1408-08

A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms

1
Department of Medicinal Chemistry, Faculty of Pharmacy and Drug Design and Development Research Center, Tehran University of Medical Sciences, Tehran 141556451, Iran
2
Department of Human Ecology, School of Public Health, Tehran University of Medical Sciences, Tehran 1417613151, Iran
3
Department of Pharmacoeconomy and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
*
Author to whom correspondence should be addressed.
Received: 12 August 2014 / Accepted: 23 September 2014 / Published: 23 September 2014
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Abstract

Fingolimod is an immunosuppressive agent which is used for the prophylaxis of organ transplantation rejection or multiple sclerosis treatment. In this study, systematic forced degradation studies on fingolimod bulk powder were performed to develop a stability-indicating HPLC method. Separation of fingolimod and its degradation products was achieved on a Nova-Pak C8 column. The mobile phase was a mixture of potassium dihydrogenphosphate 50 mM (pH 3.0) and acetonitrile (45:55, v/v) at a flow rate of 1 ml/min. The proposed method was linear in the range of 0.125–20 μg mL−1. The within-day and between-day coefficients of variation were in the range of 0.6–1.2%. The developed method was successfully applied for the determination of the fingolimod amount in pharmaceutical dosage forms.
Keywords: Fingolimod; HPLC; Stability-Indicating; Stress degradation Fingolimod; HPLC; Stability-Indicating; Stress degradation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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SOURI, E.; ZARGARPOOR, M.; MOTTAGHI, S.; AHMADKHANIHA, R.; KEBRIAEEZADEH, A. A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms. Sci. Pharm. 2015, 83, 85-93.

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