首批草酸艾司西酞普兰杂质A国家药品对照品的研制  

Establishment of the First Batch of National Drug Reference Standard of Escitalopram Oxalate Impurity A

作　　者：倪雪 周晓力[2] 孙长迎 许卉[1] 尹利辉[2] Ni Xue;Zhou Xiaoli;Sun Changying;Xu Hui;Yin Lihui(Yantai University,Yantai 264003,China;National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,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,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药事》2024年第12期1413-1420,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:研制首批草酸艾司西酞普兰杂质A国家药品对照品,用于对草酸艾司西酞普兰片以及氢溴酸西酞普兰片等品种进行质量控制,保证患者用药安全。方法:采用LC-MS及NMR等技术对草酸艾司西酞普兰杂质A的结构进行确证。采用HPLC法进行纯度分析,采用质量平衡法计算草酸艾司西酞普兰杂质A的含量,并用DSC定量法和核磁共振定量法辅助定值。结果:表征了草酸艾司西酞普兰杂质A对照品的结构,并测定其含量为97.5%。结论:建立了首批草酸艾司西酞普兰杂质A国家药品对照品,可满足相关药品国家标准中的有关物质检查。Objective:To develop the first batch of national drug reference standard of Escitalopram Oxalate Impurity A,which will be used for quality control of escitalopram oxalate tablets and citalopram hydrobromide tablets and so on,in order to ensure the drug safe.Methods:The structure of Escitalopram Oxalate Impurity A was confirmed using LC-MS and NMR.HPLC was employed for purity analysis.The content of Escitalopram Oxalate Impurity A was calculated using the mass balance method,with DSC and qNMR methods used for auxiliary valuation.Results:The structure of the first batch of national drug reference standard of Escitalopram Oxalate Impurity A was characterized and its content was determined to be 97.5%.Conclusion:The first batch of national drug reference standard of Escitalopram Oxalate Impurity A was established,meeting the needs of the related substances inspection in the national standards for these relevant drugs.

关 键 词：草酸艾司西酞普兰 对照品 结构确证 质量平衡法 ^(19)F核磁定量法 

分 类 号：R917[医药卫生—药物分析学]