遗传毒性杂质种类繁多且通常痕量存在于药物中，而色谱-质谱联用技术具有相对更高的灵敏度和选择性，极适用于分析药物中的遗传毒性杂质。主要介绍了如何根据遗传毒性杂质的极性、挥发性、热不稳定性等理化性质建立合适的色谱-质谱联用技术，并综述了气相色谱、液相色谱、超高液相色谱、亲水性相互作用色谱、超临界流体色谱、毛细管电泳色谱6种色谱技术与质谱联用在遗传毒性杂质（如亚硝胺类、磺酸酯类、卤代烷烃类等）检测中的研究进展，从而为建立科学合理的遗传毒性杂质检测方法提供参考。

The genotoxic impurities are various and usually trace in drugs, while the chromatographic-mass spectrometry technique has relatively high sensitivity and selectivity, which is extremely suitable for the analysis of genotoxic impurities in drugs. This article mainly introduces how to establish a suitable chromatographic-mass spectrometry technique according to the physicochemical properties of genotoxic impurities such as polarity, volatility and thermal instability, as well as the research progress of gas chromatography, high performance liquid chromatography, ultra performance liquid chromatography, hydrophilic interaction liquid chromatograph, supercritical fluid chromatography, capillary electrophoresis chromatography combined with mass spectrometry in the detection of genotoxic impurities such as nitrosamines, sulfonates, halogenated alkanes, etc., so as to provide a reference for the establishment of scientific and reasonable detection methods of genotoxic impurities.

R927.1

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学科建设资助项目(1030050090124)