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 C1...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.展开更多
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 × 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.
