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

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• 作者：Niamh O¡¯Connor ; Michael Geary ; Mary Wharton ; Paul Sweetman
• 关键词：Flunarizine ; Sub 2  ; ¦Ìm column ; Active pharmaceutical ingredient ; HPLC
• 刊名：Journal of Pharmaceutical Analysis
• 出版年：2013
• 出版时间：June, 2013
• 年：2013
• 卷：3
• 期：3
• 页码：211-214
• 全文大小：652 K

文摘

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¡Á4.6 mm i.d., 1.9 ¦Ìm 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.