Method for determination of lansoprazole Langshaw chloride

Determination of lansoprazole in Langshaw chloride of the present invention, the use of high performance liquid chromatography in impurity reference external standard, reverse-phase column was strongly polar column, mobile phase of acetonitrile -pH6. 2 ~ 6.5 phosphate buffer, diluent is acetonitrile -pH10.5 phosphate buffer, detection wavelength of 210nm. The method of the present invention is a current mainstream high performance liquid chromatography (HCLP), high sensitivity, experiments showed that the detection limit of 0.5ppm, fully meet the "genotoxic impurity limits Guide" to lansoprazole of genotoxic substances 8ppm control requirements, specific, and accurate. According to ICH Guidelines "Q2b methodology" in method validation, the results are in line with the requirements of the Guiding Principles.