首批利伐沙班国家对照品的研制  

Establishment of the first batch of national reference standard of rivaroxaban

作　　者：刘倩[1] 冯玉飞[1] 綦梦洁 杨东升 关皓月[1] 牛剑钊[1] 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)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》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)。

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.

关 键 词：利伐沙班 标准物质定值 质量平衡法 对照品 HPLC法 

分 类 号：R917[医药卫生—药物分析学]