CAJ | 학술논문

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。
약물유관물질적공제시약품안전、유효적중요보장，시평개약품질량우렬적관건지표。고효액상색보（ HPLC）법시유관물질분석최상용적방법지일，근년래，초고효액상색보（ UPLC）법재약물유관물질분석영역적응용축점증다。 UPLC법비상규적HPLC법경가고효、쾌속，가보증주성분여각유관물질적색보봉완전분리，대대축단검측시간。본문종UPLC법측정원료약、제제적유관물질，동시측정약물적함량화유관물질등방면토론료UPLC법재유관물질분석중적연구진전，위약물분석공작자재유관물질연구시제공삼고。
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.