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

With the implementation of the guiding principles of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D elemental impurities and China's accession to ICH, ICH Q3D was implemented in January 2020 in China, and elemental impurities in drugs had gradually become the focus of attention. Inductively coupled plasma atomic emission spectrometry (ICP-AES) and inductively coupled plasma mass spectrometry (ICP-MS) were two methods for the determination of elemental impurities, which were recommended by USP〈233〉, and became alternative methods for the determination of multi-elemental impurities. 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 reported in the literature in recent years for active pharmaceutical ingredients (API), raw materials and drugs were covered, and the interference in the process of analyzing drugs by ICP-AES and ICP-MS were discussed. At present, it was a trend to to determine the elemental impurities in drugs by ICP-AES and ICP-MS. The review (75 ref. cited) could provide some references for the development of such methods for the determination of elemental impurities.