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 (50mmÃ4.6mm i.d., 1.9μm particle size) with a gradient mobile phase of ac...
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| Main Authors: | , , , |
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| Format: | Book |
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Elsevier,
2013-06-01T00:00:00Z.
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| Summary: | 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., 1.9μm 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 2μm column, Active pharmaceutical ingredient, HPLC |
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| Item Description: | 2095-1779 10.1016/j.jpha.2012.12.005 |