Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

Niamh OâConnor; Michael Geary; Mary Wharton; Paul Sweetman

doi:10.1016/j.jpha.2012.12.005

Journal of Pharmaceutical Analysis (Jun 2013)

Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

Niamh OâConnor,
Michael Geary,
Mary Wharton,
Paul Sweetman

Affiliations

Niamh OâConnor: Department of Applied Science, Limerick Institute of Technology, Moylish Park, Ireland
Michael Geary: Department of Applied Science, Limerick Institute of Technology, Moylish Park, Ireland; Corresponding author. Tel.: +353 061 208208x423; fax: +353 061 208209.
Mary Wharton: Department of Applied Science, Limerick Institute of Technology, Moylish Park, Ireland
Paul Sweetman: Janssen Pharmaceutical Limited, Little Island, Cork, Ireland

DOI: https://doi.org/10.1016/j.jpha.2012.12.005
Journal volume & issue: Vol. 3, no. 3
pp. 211 – 214

Abstract

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A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50mmÃ4.6mm i.d., 1.9Î¼m particle size) with a gradient mobile phase of acetonitrileâammonium acetateâtetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8mL/min and UV detection at 230nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented. Keywords: Flunarizine, Sub 2Î¼m column, Active pharmaceutical ingredient, HPLC

Published in Journal of Pharmaceutical Analysis

ISSN: 2095-1779 (Print); 2214-0883 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Therapeutics. Pharmacology
Website: https://www.sciencedirect.com/journal/journal-of-pharmaceutical-analysis

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