奥美拉唑肠溶胶囊有关物质检查方法研究

Studies on Methods for Determination of Related Substances in Omeprazole Enteric-coated Capsules

目的确立适合的奥美拉唑肠溶胶囊中有关物质HPLC测定方法,以达到控制奥美拉唑肠溶胶囊质量的目的。方法采用C18色谱柱,以甲醇-水-三乙胺-磷酸(55:45:0.3:0.12)为流动相,检测波长为280nm。结果利用该色谱条件能有效检出奥美拉唑肠溶胶囊中的降解产物,最低检出限为2ng(0.05%)。结论该方法能够检测出奥美拉唑肠溶胶囊的降解情况,对质量进行有效控制。

Objective To establish an appropriate HPLC method to determine related substances in Omeprazole Enteric-coated Capsules,in order to control the quality effective.Methods C18 column was used with methanol-water-triethylamine-phosphoric acid（55∶45∶0.3∶0.12）as mobile phase.The detective wavelength was 280nm.Results The related substances could be determined by HPLC.The detection limit was 2ng.Conclusion The HPLC method can determine the related substances in Omeprazole Enteric-coated Capsules accurately which meet the requirements of quality control.