O'Connor Niamh, Geary Michael, Wharton Mary, Sweetman Paul
Department of Applied Science, Limerick Institute of Technology, Moylish Park, Ireland.
Janssen Pharmaceutical Limited, Little Island, Cork, Ireland.
J Pharm Anal. 2013 Jun;3(3):211-214. doi: 10.1016/j.jpha.2012.12.005. Epub 2012 Dec 21.
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.