化学
色谱法
高效液相色谱法
杂质
乙腈
检出限
定量分析(化学)
分析物
分析化学(期刊)
作者
Adrian Leistner,Ulrike Holzgrabe
标识
DOI:10.1016/j.jpba.2021.113982
摘要
Abstract The quality control of active pharmaceutical ingredients (APIs) is a very important aspect for drug products entering the market. However, also for the well-established drugs, there ought to be a state-of-the-art impurity control. Some of the pharmacopoeial tests for related substances still make use of thin layer chromatography, even though selectivity and sensitivity are suboptimal. Here, we report on the development of a new gradient high performance liquid chromatography (HPLC) method for dapsone in order to replace the currently described pharmacopoeial TLC method. The separation of all relevant components was achieved on a C18 stationary phase (Waters XTerra® RP18 5 μm 4.6 × 250 mm) using a water-acetonitrile gradient. A limit of detection (LOD) of 0.02% was registered for all specified impurities. Additionally, within this study an “impurity of an impurity” was identified by means of LC–MS/MS.
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