基因毒性杂质分析方法和前处理技术的研究进展

基因毒性杂质对人们的用药安全造成了严重威胁。由于性质活泼、稳定性差，基因毒性杂质的痕量分析极具挑战性。本文系统地介绍9种基因毒性杂质（烷基卤化物、双烷基硫酸酯、环氧化合物、肼类化合物、四甲基哌啶氧化物、芳香胺、硼酸、磺酸酯和乙酰胺）的分析方法（包括GC、LC、GC-MS和LC-MS法等）及其前处理技术（包括顶空分析法、固相萃取法和衍生化法等），为更好地选择和建立基因毒性杂质的检测方法提供重要参考。

Genotoxic impurities pose a serious threat to people's safety of medication. Trace-level analysis of genotoxic impurities is challenging due to the active property and poor stability. This article systematically introduces the analytical methods including GC, LC, GC-MS and LC-MS, and the pre-treatment techniques containing headspace, solid-phase extraction and derivatization for the nine kinds of genotoxic impurities:alkyl halides, dialkyl sulfates, epoxides, hydrazines, TEMPO, aromatic amines, boronic acids, sulfonate esters and acetamide. It will be beneficial for the better selection and establishment of analysis methods for genotoxic impurities.