青蒿素哌喹片杂质的初步研究  

Primary analysis and evaluation of impurities in artemisinin and piperaquine tablets

作　　者：王铁杰[1,2] 殷果[1,2] 闫研[1,2] 李媛[1,2,3] 丁振浩[1,2] 宋茜[1,2,3] 韩东岐[1,2] 

机构地区：[1]深圳市药品检验所,深圳518057 [2]深圳药品质量标准研究重点实验室,深圳518057 [3]沈阳药科大学,沈阳110016

出　　处：《药物分析杂志》2014年第3期465-470,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：全球基金项目国家药品标准提高(GF2012-40)

摘　　要：目的:对青蒿素哌喹片中主要杂质进行初步研究。方法:采用HPLC法,以Shim-pack VP-ODS C18(4.6 mm×150mm,5μm)为分析柱;乙腈-水(50∶50)为流动相,流速为1.0 mL·min-1;检测波长为210 nm。采用LC-MS/MS高分辨质谱对其主要杂质进行结构研究并进行溯源。结果:主峰与各杂质分离良好,检测出4个主要杂质,对其中3个主要杂质进行了定性研究,为其工艺和质量控制提供了参考依据。结论:青蒿素哌喹片对酸、碱、热、光照不稳定,因而在本品生产及贮藏时应尽量避免光照及高温,防止药品发生降解。Objective： To study the major impurities of artemisinin and piperaquine tablets. Methods： HPLC meth- od was employed. Shim -pack VP- ODS C18（4.6 mm x 150 mm,5 μm） column was used,the mobile phase was composed of acetonitrile- water（50： 50）. The flow rate was 1.0 mL · min-1. The detection wavelength was 210 nm. High resolution LC - MS/MS was employed to identify the main impurities. Results： Main peak and impurities were separated well under the established HPLC condition. Four impurities were detected, and three of them were characterized by TOF/MS. Conclusion： The artemisinin and piperaquine tablets were unstable in the acid, alkali, illumination and thermal environment, so thermal and illumination conditions should be avoided during manufactur- ing and storage process in case of degradation.

关 键 词：抗疟药 青蒿素哌喹片 杂质 高效液相色谱 液相色谱-质谱联用 

分 类 号：R917[医药卫生—药物分析学]