Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide

A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250 mm×4.6 mm, 5 μm) with mobile phase consisting of water–acetonitrile (40:60, v/v) with a flow rate of 0.8 mL/min (UV detection 215 nm). Linearity was obs...

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Detalles Bibliográficos
Autores principales: Sai Pavan Kumar, B., Mathrusri Annapurna, M., Pavani, S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2013
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760934/
https://www.ncbi.nlm.nih.gov/pubmed/29403798
http://dx.doi.org/10.1016/j.jpha.2012.08.003
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author Sai Pavan Kumar, B.
Mathrusri Annapurna, M.
Pavani, S.
author_facet Sai Pavan Kumar, B.
Mathrusri Annapurna, M.
Pavani, S.
author_sort Sai Pavan Kumar, B.
collection PubMed
description A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250 mm×4.6 mm, 5 μm) with mobile phase consisting of water–acetonitrile (40:60, v/v) with a flow rate of 0.8 mL/min (UV detection 215 nm). Linearity was observed over the concentration range 1.0–200 μg/mL (R(2)=0.9997) with regression equation y=113190 x+63053. Rufinamide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Rufinamide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines.
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spelling pubmed-57609342018-02-05 Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide Sai Pavan Kumar, B. Mathrusri Annapurna, M. Pavani, S. J Pharm Anal Article A stability-indicating RP-HPLC method was developed and validated for the determination of Rufinamide in tablet dosage forms using C 18 column (250 mm×4.6 mm, 5 μm) with mobile phase consisting of water–acetonitrile (40:60, v/v) with a flow rate of 0.8 mL/min (UV detection 215 nm). Linearity was observed over the concentration range 1.0–200 μg/mL (R(2)=0.9997) with regression equation y=113190 x+63053. Rufinamide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Rufinamide is more sensitive towards acidic degradation. The method was validated as per ICH guidelines. Xi'an Jiaotong University 2013-02 2012-09-05 /pmc/articles/PMC5760934/ /pubmed/29403798 http://dx.doi.org/10.1016/j.jpha.2012.08.003 Text en © 2013 Xi'an Jiaotong University http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
spellingShingle Article
Sai Pavan Kumar, B.
Mathrusri Annapurna, M.
Pavani, S.
Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
title Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
title_full Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
title_fullStr Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
title_full_unstemmed Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
title_short Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
title_sort development and validation of a stability indicating rp-hplc method for the determination of rufinamide
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760934/
https://www.ncbi.nlm.nih.gov/pubmed/29403798
http://dx.doi.org/10.1016/j.jpha.2012.08.003
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