电感耦合等离子体原子发射光谱法和电感耦合等离子体质谱法检测药品中元素杂质的研究进展

Research Progress of Determination of Elemental Impuritiesin Drugs by ICP-AES and ICP-MS

随着国际人用药品注册技术协调会(ICH)Q3D元素杂质指导原则的实施及中国加入ICH,中国于2020年1月执行ICH Q3D,药物中元素杂质逐渐成为人们的关注热点.电感耦合等离子体原子发射光谱法(ICP-AES)和电感耦合等离子体质谱法(ICP-MS)是两种美国药典(USP)‹233›推荐的元素杂质的检测方法,并成为多元素杂质检测方法的替代方法.概述了ICH Q3D规定元素杂质及其来源,总结了两种方法的主要优点、局限性及样品制备方法,涵盖了近年来文献中报道的主要用于活性药物成分(API)、原料和药物的应用,讨论了在采用ICP-AES和ICP-MS分析药品过程中的干扰.目前采用ICP-AES和ICP-MS检测药物中的元素杂质已经是一种趋势,综述(所引文献75篇)可为元素杂质检测方法的开发提供一定的参考.

Withtheimplementation ofthe guiding principles of TheInternational Councilfor Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)Q3D elemental impurities and China′s accessiontoICH,ICH Q3D was implemented in January 2020 in China,and elemental impurities in drugs had gradually becomethefocus of attention.Inductively coupled plasma atomic emission spectrometry(ICP-AES)and inductivelycoupled plasma mass spectrometry(ICP-MS)were two methods for the determination of elemental impurities,which wererecommendedby USP‹233›,andbecamealternative methodsforthedeterminationof multI^(-)elementalimpurities.Element impurities required in ICH Q3D and their sources were summarized,the main advantages,limitations and sample preparation methods for the two methods were summarized,the applications reportedintheliteratureinrecent yearsforactive pharmaceuticalingredients(API),raw materials and drugs were covered,andtheinterferenceintheprocessofanalyzingdrugs byICP-AESandICP-MS werediscussed.Atpresent,it wasatrendtoto determinetheelementalimpuritiesindrugs byICP-AESandICP-MS.Thereview(75 ref.cited)could providesomereferencesforthe development ofsuch methodsforthe determination ofelementalimpurities.