富马酸喹硫平杂质对照品的研制
Development of impurity reference substance for quetiapine fumarate
李增鑫 1周晓力 2张津泽 2刘万卉 1尹利辉2
作者信息
- 1. 烟台大学,烟台 264003
- 2. 中国食品药品检定研究院,北京 102629
- 折叠
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.
Abstract
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Key words
impurity of quetiapine fumarate/standard substances/structure confirmation/mass balance method/quantitative nuclear magnetic resonance引用本文复制引用
基金项目
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)
出版年
2024
NETL
NSTL
万方数据