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建立了液相色谱-质谱法检测并初步鉴定西司他丁钠原药中的有关物质,并考察了本法的专属性及有关物质的降解途径。采用Sepax HP C18色谱柱,以A:乙腈-0.1%甲酸水溶液(30︰70),B:0.1%甲酸水溶液为流动相进行梯度洗脱,0～30 min,15%～100%流动相A,30～45 min,100%流动相A。采用正离子模式采集数据。原药共检测出10个有关物质,推测分别为欧洲药典中收载的有关物质A、B、C,A的同分异构体,西司他丁酸降解产物,4个西司他丁同分异构体和1个西司他丁二聚物。
A liquid chromatography-mass spectrometry (LC-MS / MS) method was established to detect and identify the related substances in the original drug of cilastatin. The specificities of this method and the degradation of related substances were also investigated. The mobile phase A was eluted with a mobile phase of Sepax HP C18 with A: acetonitrile-0.1% formic acid (30:70) and B: 0.1% formic acid as mobile phase. The mobile phase A was eluted at 0-30 min with 15-100% 30 ~ 45 min, 100% mobile phase A. Data collected using positive mode. The original drug detected 10 related substances, presumed to be contained in the European Pharmacopoeia related substances A, B, C, A isomers, cilastatin degradation products, four cilastatin with Isomers and 1 cilastatin dimer.