遺傳毒性雜質(zhì)種類繁多且通常痕量存在于藥物中，而色譜-質(zhì)譜聯(lián)用技術(shù)具有相對更高的靈敏度和選擇性，極適用于分析藥物中的遺傳毒性雜質(zhì)。主要介紹了如何根據(jù)遺傳毒性雜質(zhì)的極性、揮發(fā)性、熱不穩(wěn)定性等理化性質(zhì)建立合適的色譜-質(zhì)譜聯(lián)用技術(shù)，并綜述了氣相色譜、液相色譜、超高液相色譜、親水性相互作用色譜、超臨界流體色譜、毛細管電泳色譜6種色譜技術(shù)與質(zhì)譜聯(lián)用在遺傳毒性雜質(zhì)（如亞硝胺類、磺酸酯類、鹵代烷烴類等）檢測中的研究進展，從而為建立科學(xué)合理的遺傳毒性雜質(zhì)檢測方法提供參考。

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

國家藥品監(jiān)督管理局化學(xué)藥品質(zhì)量研究與評價重點實驗室學(xué)科建設(shè)資助項目(1030050090124)