[關鍵詞]
[摘要]
藥品的雜質含量是衡量藥物質量的重要指標,也是藥品質量研究中一項極為關鍵的內容。藥物中的雜質含量低、來源廣、結構多與主成分類似,必須選擇合適的分析技術進行研究。LC-MS聯(lián)用技術結合了色譜的高分離能力和質譜的高選擇性、高靈敏度及能夠提供相對分子質量與結構信息的優(yōu)點,在食品分析、環(huán)境分析和醫(yī)藥研究等許多領域已得到了廣泛應用。隨著聯(lián)用技術的日趨完善,以及色譜、質譜新技術的應用,LC-MS聯(lián)用技術成為雜質分析中廣泛采用的方法。綜述了近幾年LC-MS技術在化學藥雜質研究中有關雜質譜、工藝雜質和降解產物中的應用。
[Key word]
[Abstract]
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.
[中圖分類號]
[基金項目]