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[摘要]
药品的杂质含量是衡量药物质量的重要指标,也是药品质量研究中一项极为关键的内容。药物中的杂质含量低、来源广、结构多与主成分类似,必须选择合适的分析技术进行研究。LC-MS联用技术结合了色谱的高分离能力和质谱的高选择性、高灵敏度及能够提供相对分子质量与结构信息的优点,在食品分析、环境分析和医药研究等许多领域已得到了广泛应用。随着联用技术的日趋完善,以及色谱、质谱新技术的应用,LC-MS联用技术成为杂质分析中广泛采用的方法。综述了近几年LC-MS技术在化学药杂质研究中有关杂质谱、工艺杂质和降解产物中的应用。
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[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.
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