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

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 (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of...

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Detalles Bibliográficos
Autores principales: O’Connor, Niamh, Geary, Michael, Wharton, Mary, Sweetman, Paul
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/PMC5760976/
https://www.ncbi.nlm.nih.gov/pubmed/29403819
http://dx.doi.org/10.1016/j.jpha.2012.12.005
Descripción
Sumario: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 (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile–ammonium acetate–tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.

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