兰索拉唑有关物质测定方法的比较研究  

Comparative Study on Determination Methods of Lansoprazole Related Substances

作　　者：陈苑[1] 宋粉云[2] 

机构地区：[1]广东省中医院,广东广州510120 [2]广东药学院药科学院,广东广州510006

出　　处：《中国药业》2015年第11期57-59,共3页China Pharmaceuticals

摘　　要：目的比较不同国家药典中兰索拉唑有关物质的检测方法。方法采用2010年版《中国药典·第一增本》(以下简称Ch P2010)、35版《美国药典》(以下简称USP35)、7.0版《欧洲药典》(以下简称EP7.0)所收载的兰索拉唑有关物质质量标准中的方法,分别对兰索拉唑有关物质进行测定,对其色谱行为、分离效能、已知杂质方法学、有关物质测定结果等进行比较。结果 USP35中兰索拉唑有关物质的流动相系统较EP7.0和Ch P2010收载的流相系统对兰索拉唑杂质的分离效能更好,而采用EP7.0有关物质方法中收载的溶剂对杂质的溶解力更强。结论 Ch P2010兰索拉唑有关物质的测定方法与欧美药典相比尚存在较大差距,建议Ch P2010在以后的修订中,将兰索拉唑有关物质的测定方法改为USP35的流动相系统,溶剂则采用EP7.0的溶剂,并借鉴欧美药典制定限度。Objective To compare the determination methods of lansoprazole related substances in the pharmacopoeias of difference countries. Methods The lansoprazole related substances were determined by adopting the methods of lansoprazole related substances quality standard contained in Chinese Pharmacopeia version 2010（Chp2010）, US Pharmacopeia edition 35（USP35） and European Pharmacopeia edition 7. O（EP7.0）. Their chromatographic behavior, separation efficiency, known impurities methodology and related substances determination results were performed the comparison and research. Results The mobile phase system for the determination of lansoprazole related substances in USP35 was better for the lansoprazole impurities separation than that in Chp2010 and EP7.0, while adopting the solvent contained in the related substances methods of EP7.0 had stronger dissolving capacity on impurity. Conclusion The determination methods of lansoprazole related substances have large difference between Chp2010 with USP35 and EP7. 0. It is suggested that in the later revision of Chp2010, the determination methods of lansoprazole related substances will be instead by the mobile system in USP35 and the solvent will adopt the solvent in EP7. 0, moreover the limitation will be formulated by using American Pharmacopeia and European Pharmacopeia as reference.

关 键 词：兰索拉唑 有关物质 中国药典 美国药典 欧洲药典 

分 类 号：R927.11[医药卫生—药学] R975.6