藥品的雜質(zhì)含量是衡量藥物質(zhì)量的重要指標(biāo)，也是藥品質(zhì)量研究中一項(xiàng)極為關(guān)鍵的內(nèi)容。藥物中的雜質(zhì)含量低、來源廣、結(jié)構(gòu)多與主成分類似，必須選擇合適的分析技術(shù)進(jìn)行研究。LC-MS聯(lián)用技術(shù)結(jié)合了色譜的高分離能力和質(zhì)譜的高選擇性、高靈敏度及能夠提供相對分子質(zhì)量與結(jié)構(gòu)信息的優(yōu)點(diǎn)，在食品分析、環(huán)境分析和醫(yī)藥研究等許多領(lǐng)域已得到了廣泛應(yīng)用。隨著聯(lián)用技術(shù)的日趨完善，以及色譜、質(zhì)譜新技術(shù)的應(yīng)用，LC-MS聯(lián)用技術(shù)成為雜質(zhì)分析中廣泛采用的方法。綜述了近幾年LC-MS技術(shù)在化學(xué)藥雜質(zhì)研究中有關(guān)雜質(zhì)譜、工藝雜質(zhì)和降解產(chǎn)物中的應(yīng)用。

The impurity content in drug is a significant indicator of measuring the drug quality, also is one of the important contents of drug quality control. It is necessary to develop an optimal analysis technique to research the drug impurity, because of its low content level, varieties of sources, and main similar-structured compositions. LC-MS technology has been widely used in the field of food analysis, environment analysis, and medicine research, which can not only reach the point of high separating capacity of chromatography but also be provided with high selectivity, sensitivity, and relative molecular mass and structure information of mass spectrum. With the increasing improvement of hyphenated technology, and the application of chromatography and mass spectrum, LC-MS hyphenated technology has been a common method in impurity analysis. The application of LC-MS hyphenated technology in impurity profiling, processed impurity, and degradation impurity during the research of chemical drug impurity in recent years is reviewed in this paper.