HPLC Method for the Enantiomeric Purity of Eletriptan Hydrobromide

摘要

An isocratic chiral stationary phase high-performance liquid chromatographic (CSP-HPLC) method has been developed and validated for the quantitation of (S)-isomer in eletriptan hydrobromide. Separation was achieved with a Chiralpak AD column. The ratio of n-hexane, ethanol, diethyl amine and trifluoroacetic acid in the mobile phase were optimized to obtain the best separation. UV detection was performed at 223 nm. The described method is linear over a range of limit of quantification ～1.5 ng/mL of (S)-isomer. The mean recovery of (S)-isomer was found to be in the range of 101-102 %. The method is simple, rapid, accurate, selective and precise, useful in the quality control of bulk manufacturing.