摘要
药物有关物质的控制是药品安全、有效的重要保障,是评价药品质量优劣的关键指标。高效液相色谱(HPLC)法是有关物质分析最常用的方法之一,近年来,超高效液相色谱(UPLC)法在药物有关物质分析领域的应用逐渐增多。UPLC法比常规的HPLC法更加高效、快速,可保证主成分与各有关物质的色谱峰完全分离,大大缩短检测时间。本文从UPLC法测定原料药、制剂的有关物质,同时测定药物的含量和有关物质等方面讨论了UPLC法在有关物质分析中的研究进展,为药物分析工作者在有关物质研究时提供参考。
The control of drug related substances is an important guarantee for drug safety and effective. High performance liquid chromatography (HPLC) is one of the most commonly used methods in the analysis of related substances. In recent years, application of ultra high performance liquid chromatography (UPLC) in the analysis of related substances in drugs gradually increased. Compared to HPLC method, UPLC method is more efficient, rapid, ensure the chromatographic peak of principal component and the related sub- stances completely separated, and greatly shorten the detection time. In this article, determination of related substances in the raw mate- rial medicine and preparation, simultaneous determination of drug content and related substances by UPLC were discussed, providing ref- erences for the study of the related substances analysis.
出处
《中国药物评价》
2015年第5期277-279,共3页
Chinese Journal of Drug Evaluation
关键词
超高效液相色谱法
药物
有关物质
Ultra high performance liquid chromatography (UPLC)
Drug
Related substances