摘要
目的:建立供含量测定用的首批利伐沙班国家对照品。方法:应用红外光谱、核磁共振和液质联用仪对利伐沙班进行结构确证,采用HPLC法测定样品色谱纯度,同时测定水分和炽灼残渣,以质量平衡法计算利伐沙班的含量。结果:确证利伐沙班的结构,确定首批利伐沙班对照品含量为99.6%。结论:首批利伐沙班化学对照品的研制可作为利伐沙班原料及其相关制剂的鉴别和含量测定用对照品。
Objective:To establish the first batch of national reference standard of rivaroxaban.Methods:The structure of rivaroxaban was confirmed by IR,NMR and LC-MS spectroscopy.The purity of rivaroxaban was determined by HPLC.Moreover,moisture and residual ignition were determined.The content of rivaroxaban was calculated by mass balance method.Results:The structure of rivaroxaban was confirmed.The content of the first batch of national reference standard of rivaroxaban was assigned as 99.6%.Conclusion:The first batch of national reference standard of rivaroxaban can be applied for the identification and content determination of rivaroxaban and its related preparations.
作者
刘倩
冯玉飞
綦梦洁
杨东升
关皓月
牛剑钊
LIU Qian;FENG Yu-fei;QI Meng-jie;YANG Dong-sheng;GUAN Hao-yue;NIU Jian-zhao(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第6期572-575,共4页
Chinese Journal of New Drugs
基金
国家“重大新药创制”科技重大专项资助项目(2017ZX09101001)。
关键词
利伐沙班
标准物质定值
质量平衡法
对照品
HPLC法
rivaroxaban
certification of standard material
mass balance methods
reference substance
HPLC
作者简介
刘倩,女,博士,研究员,研究方向:药检药理。E-mail:liuqian@nifdc.org.cn;通讯作者:牛剑钊,男,硕士,副主任药师,研究方向:药检药理。联系电话:(010)67095456,E-mail:njz@nifdc.org.cn。
