摘要
目的 比较国际主流机构色谱-质谱法分析物定性确证的技术文件,为完善《中国药典》2020年版相关技术要求提出建议。方法 通过查阅《中国药典》2020年版四部以及欧盟委员会、美国食品药品监督管理局、世界反兴奋剂组织相关指导原则和技术文件,比较关键参数的差异。结果 随着分析技术的发展,不同机构对于色谱-质谱法分析物定性确证的标准处于不断更新之中;现有技术文件对具体技术参数的要求也不尽相同。结论 建议《中国药典》2020年版在通则0431质谱法中明确色谱-质谱法分析物定性确证的标准,以便提供更详细的指导,保证相关方法更加科学、规范地执行。
OBJECTIVE To compare technical documents on criteria for chromatographic-mass spectrometric confirmation of the identification of analytes in major international organizations,and provide suggestion for updates of corresponding technical specifications in Chinese Pharmacopeia.METHODS Chinese Pharmacopeia volumeⅣ,the guidance or technical documents in European Commission,Food and Drug Administration,and World Anti-Doping Agency were reviewed.The key parameters in relevant technical documents were compared.RESULTS The criteria in different organizations were updated following the repaid development of analytical techniques.Existing technical documents also vary in their requirements for specific technical parameters.CONCLUSION It is suggested that the criteria for chromatographic-mass spectrometric confirmation of the identification of analytes in Chinese Pharmacopeia general chapter 0431 mass spectrometry should be specified to provide more detailed guidance and ensure relevant methods executed scientifically and standardly.
作者
何风艳
周亚楠
郭日新
刘静
何轶
魏锋
HE Fengyan;ZHOU Yanan;GUO Rixin;LIU Jing;HE Yi;WEI Feng(National Institutes for Food and Drug Control,Beijing 100050,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)
出处
《中国药学杂志》
北大核心
2025年第4期422-427,共6页
Chinese Pharmaceutical Journal
关键词
色谱-质谱法
定性确证
标准
指导原则
chromatographic-mass spectrometry
identification confirmation
criteria
issued guidance
