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

倪雪 ¹周晓力 ²孙长迎 ²许卉 ¹尹利辉²

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作者信息

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
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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.

Abstract

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/19F核磁定量法

Key words

Escitalopram Oxalate/reference standard/structure confirmation/mass balance method/19F quantitative nuclear magnetic resonance

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出版年

2024

中国药事

中国食品药品检定研究院（中国药品生物制品检定所）

中国药事

CSTPCD

影响因子：0.844

ISSN：1002-7777

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