药物杂质结构鉴定的研究进展

药物杂质是指任何影响药物纯度的物质,它是反映药物质量的重要指标。药物中的杂质一方面导致药物活性成分含量降低,影响药物的治疗效果;另一方面毒性杂质在用药过程中会威胁人类的健康。因此必须选择合适的分析技术进行研究,确定其来源,并对其结构进行鉴定。液质联用技术灵敏度高、专属性强、重现性好,能提供丰富的结构信息,是目前药物杂质结构鉴定分析领域应用最为广泛的一种技术。本文对近年来液质联用技术在抗生素药物、喹诺酮类药物、沙坦类药物及其他药物中杂质的结构鉴定方面进行综述,并对其发展趋势进行展望。

Research Progress in Structural Identification of Drug Impurities

Drug impurity refers to any substance that affects the purity of a drug, and it is an important indicator of drug quality. The impurities in the drug, on one hand, lead to a decrease in the content of the active ingredient of the drug, which affects the therapeutic effect of the drug, and on the other hand, the toxic impurities may threaten human health during the course of administration. Therefore, it is necessary to select suitable analysis techniques for research, determine its source, and identify its structure. Liquid chromatography-mass spectrometry has high sensitivity, strong specificity, good reproducibility, and can provide rich structure information. It is currently the most widely used technology in the field of structural identification and analysis of drug impurities. This article reviews the recent LC-MS technology in the structure identification of impurities in antibiotics, quinolones, sartans and other drugs, and the development trend of LC-MS technology is prospected.