阿莫西林/克拉维酸钾干混悬剂有关物质测定方法的比较研究  

Comparative study on determination methods of amoxicillin and clavulanate potassium for suspension

作　　者：沈丹丹 吴群 胡幸 刘映倩 姜学美 张涛 Shen Dan-dan Wu Qun Hu Xing Liu Ying-qian Jiang Xue-mei Zhang Zao(Chongqing Institute for Food and Drug Control, Chongqing 401121 Chongqing Research Center for Drug Process and Quality Control Engineering, Chongqing 401121 Fuan Pharmaceutical Lybon Pharm-tech Co.,Ltd, Chongqing 401121)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]重庆市药物过程与质量控制工程技术研究中心,重庆401121 [3]福安药业集团重庆礼邦药物开发有限公司,重庆401121

出　　处：《中国抗生素杂志》2016年第11期848-852,共5页Chinese Journal of Antibiotics

摘　　要：目的比较不同标准中阿莫西林/克拉维酸钾干混悬剂有关物质的测定方法。方法采用2015年版《中国药典》(以下简称Ch P 2015)、2014版《英国药典》(以下简称BP2014)、同品种进口注册标准(JX20040226)所收载的阿莫西林/克拉维酸钾干混悬剂质量标准中有关物质的方法,分别测定其有关物质,对色谱行为、已知杂质系统适用性、有关物质测定结果等进行比较。结果阿莫西林/克拉维酸钾干混悬剂有关物质的测定方法存在较大差异,BP2014中有关物质的色谱条件对阿莫西林/克拉维酸钾杂质的分离效能更好。结论建议在以后的标准制定中利用系统适用性中各杂质的色谱信息,参照BP2014色谱条件,提高本品有关物质的测定方法。Objective To compare the determination methods of amoxicillin and clavulanate potassium for suspension related substances in the difference quality standard. Methods The amoxicillin and clavulanate potassium for suspension related substances were determined by adopting the methods of related substances quality standard contained in Chinese Pharmacopeia version 2015 （ChP2015）, British Pharmacopoeia edition 2014 （BP2014） and the same breed import and registration standard （JX20040226）. Their chromatographic behavior, known impurities methodology and related substances determination results were performed the comparison. Results The determination methods of amoxicillin and clavulanate potassium for suspension related substances have large difference among different quality standard. The chromatographic conditions for determination of related substances in BP2014 was better for the impurities separation. Conclusion It is suggested that in the later standard establishment, the determination methods of the samples related substances will be improved reference to the chromatographic conditions in BP2014, based on retention information of each impurity in system suitability test.

关 键 词：阿莫西林/克拉维酸钾干混悬剂 有关物质 系统适用性 中国药典 英国药典 进口注册标准 

分 类 号：R917[医药卫生—药物分析学]