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基因毒性杂质的控制策略及其在HPLC-MS中的应用
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Abstract:
在药品研发中，基因毒性杂质的评估一直是药品质量评价的重点内容，关系到药品上市的安全性。基因毒性杂质危险系数高，对人体的危害性大，选用高灵敏度、专属性良好的分析仪器并结合TTC概念选择合适的分析方法是目前控制药物中基因毒性杂质含量的核心内容。其是药物开发的重要组成部分，贯穿于整个研发过程。高效液相色谱–质谱联用技术作为药物基因毒性杂质研究的有力分析工具之一，已广泛应用于多种基因毒性杂质的分析与鉴定。本文将从基因毒性杂质的概念、国内外的法规要求、以及HPLC-MS在基因毒性杂质中的应用进行概述，以期为基因毒性杂质的有效控制提供参考依据，保证患者用药安全。
In drug research and development, the evaluation of genotoxic impurities has always been the focus of drug quality evaluation, which is related to the safety of drug marketing. Genotoxic impurities have a high risk factor and are harmful to the human body. The selection of analytical instruments with high sensitivity and good specificity and the selection of appropriate analytical methods combined with the concept of TTC are the core content of controlling the content of genotoxic impurities in drugs. It is an important part of drug development and runs through the entire R&D process. High performance liquid chromatography-mass spectrometry, as one of the powerful analytical tools for the study of drug genotoxic impurities, has been widely used in the analysis and identification of various genotoxic impurities. This article will summarize the concept of genotoxic impurities, domestic and foreign regulatory requirements, and the application of HPLC-MS in genotoxic impuri-ties, in order to provide a reference for the effective control of genotoxic impurities and ensure drug safety for patients.
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