达托霉素在不同酸碱条件下产生的杂质及其结构研究  

Study on characterization of impurities derived from daptomycin in different pH

作　　者：张定丰[1] 夏兴[2,3] 苏永槐[1] 饶敏 孙新强[1] 戈梅 

机构地区：[1]浙江医药股份有限公司新昌制药厂,新昌312500 [2]上海来益生物药物研发中心有限责任公司,上海200240 [3]上海交通大学药学院,上海200240

出　　处：《中国抗生素杂志》2013年第10期760-764,共5页Chinese Journal of Antibiotics

摘　　要：达托霉素是一种正在临床使用的新型抗耐药菌抗生素。由于结构特点,其在不同的pH值下会产生不同的杂质。本文研究了不同pH值下达托霉素杂质的产生情况。利用分析和制备型HPLC,获得了5个主要的相关杂质。通过质谱对各杂质碎片的检测和分析,进行了结构认定。除了4个已知杂质之外,获得了一个未报道的杂质,为达托霉素氨基酸内酰胺断裂后的开环产物。Daptomycin is a new anti-resistant antibiotic, which can derive to various impurities in different pH values. In this paper, impurity profile of daptomycin in different pH values was studied. Using analytic and preparative HPLC, five related impurities of daptomycin were obtained. The structures of impurities were identified by MS and MS-MS analysis. Besides four reported impurities, an unreported impurity was obtained and identified as lactam hydrolysis product.

关 键 词：达托霉素 杂质 HPLC分析 MS-MS分析 

分 类 号：R978.1[医药卫生—药品]