富马酸喹硫平杂质对照品的研制  

Development of impurity reference substance for quetiapine fumarate

作　　者：李增鑫 周晓力[2] 张津泽 刘万卉[1] 尹利辉[2] LI Zeng-xin;ZHOU Xiao-li;ZHANG Jin-ze;LIU Wan-hui;YIN Li-hui(Yantai University,Yantai 264003,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]烟台大学,烟台264003 [2]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2024年第13期1390-1395,共6页Chinese Journal of New Drugs

基　　金：中国食品药品检定研究院关键技术研究基金资助项目(GJJS-2022-4-2);2023年度国家药品标准制修订研究课题资助项目(2023Y15)。

摘　　要：目的:对富马酸喹硫平杂质B、杂质G、杂质H、杂质I等的对照品进行标定研制,用于该品种相关国家标准中有关物质检查。方法:采用LC-MS法及核磁共振波谱(NMR)法等对杂质B、杂质G、杂质H、杂质I进行结构确证。采用HPLC法进行纯度分析,采用质量平衡法计算各个杂质的含量,并用核磁共振定量法辅助定值。结果:杂质B、杂质G、杂质H、杂质I的含量分别为98.00%,99.28%,98.94%和97.84%。结论:建立了首批富马酸喹硫平杂质B、杂质G、杂质H、杂质I的标准物质,满足了国内富马酸喹硫平及制剂的质量控制需要。Objective:The impurity reference substances B,G,H,and I were calibrated and developed,which can be used for the inspection of relevant national standards and related substances of this variety.Methods:The structures of impurities B,G,H and I were identified by LC-MS and NMR.HPLC method was used for purity analysis,mass balance method was used to calculate the content of various impurities,and quantitative nuclear magnetic resonance was used to assist in calibration.Results:The contents of impurities B,G,H and I are 98.00%,99.28%,98.94%and 97.84%,respectively.Conclusion:The first batch of national standard substances of impurities B,G,H and I of quetiapine fumarate was successfully developed,satisfying the quality control needs of quetiapine fumarate and its formulations in China.

关 键 词：富马酸喹硫平杂质 标准物质 结构确证 质量平衡法 核磁共振定量法 

分 类 号：R917[医药卫生—药物分析学]