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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(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.
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 id, 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.