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

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 fi...

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Detalles Bibliográficos
Autores principales: Souri, Effat, Zargarpoor, Mohammad, Mottaghi, Siavash, Ahmadkhaniha, Reza, Kebriaeezadeh, Abbas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Austrian Journal of Pharmaceutical Sciences 2015
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4727784/
https://www.ncbi.nlm.nih.gov/pubmed/26839803
http://dx.doi.org/10.3797/scipharm.1408-08
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author Souri, Effat
Zargarpoor, Mohammad
Mottaghi, Siavash
Ahmadkhaniha, Reza
Kebriaeezadeh, Abbas
author_facet Souri, Effat
Zargarpoor, Mohammad
Mottaghi, Siavash
Ahmadkhaniha, Reza
Kebriaeezadeh, Abbas
author_sort Souri, Effat
collection PubMed
description 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 C(8) 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.
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spelling pubmed-47277842016-02-02 A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms Souri, Effat Zargarpoor, Mohammad Mottaghi, Siavash Ahmadkhaniha, Reza Kebriaeezadeh, Abbas Sci Pharm Research Article 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 C(8) 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. The Austrian Journal of Pharmaceutical Sciences 2015 2014-09-23 /pmc/articles/PMC4727784/ /pubmed/26839803 http://dx.doi.org/10.3797/scipharm.1408-08 Text en Copyright: © Souri et al. http://creativecommons.org/licenses/by/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Souri, Effat
Zargarpoor, Mohammad
Mottaghi, Siavash
Ahmadkhaniha, Reza
Kebriaeezadeh, Abbas
A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
title A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
title_full A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
title_fullStr A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
title_full_unstemmed A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
title_short A Stability-Indicating HPLC Method for the Determination of Fingolimod in Pharmaceutical Dosage Forms
title_sort stability-indicating hplc method for the determination of fingolimod in pharmaceutical dosage forms
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4727784/
https://www.ncbi.nlm.nih.gov/pubmed/26839803
http://dx.doi.org/10.3797/scipharm.1408-08
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