首页|富马酸喹硫平杂质对照品的研制

富马酸喹硫平杂质对照品的研制

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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.
Development of impurity reference substance for quetiapine fumarate
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.

impurity of quetiapine fumaratestandard substancesstructure confirmationmass balance methodquantitative nuclear magnetic resonance

李增鑫、周晓力、张津泽、刘万卉、尹利辉

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烟台大学,烟台 264003

中国食品药品检定研究院,北京 102629

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

中国食品药品检定研究院关键技术研究基金资助项目2023年度国家药品标准制修订研究课题资助项目

GJJS-2022-4-22023Y15

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子：1.039
ISSN：1003-3734
年,卷(期)：2024.33(13)
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