LC-MS/MS法研究头孢美唑钠中有关物质  

Identification of the related substances in cefmetazole sodium by LC-MS/MS

作　　者：孔兴欣[1] 沈文斌[2] 王丽云 石金芳[1] 狄斌[1] 张韬 

机构地区：[1]中国药科大学药物分析学教研室,南京210009 [2]中国药科大学分析测试中心,南京210009 [3]浙江亚太药业股份有限公司,绍兴312030

出　　处：《中国药科大学学报》2012年第2期170-176,共7页Journal of China Pharmaceutical University

摘　　要：建立采用LC-MS/MS法对头孢美唑钠中有关物质进行定性分析。采用ODS色谱柱(250 mm×4.6 mm,5μm),以1%甲酸水溶液-乙腈为流动相线性梯度洗脱;柱后分流,80%流出液经PDA检测,20%流出液电喷雾离子化MS测定。采集有关物质的PDA谱、质谱母离子及子离子谱,进行解析推测有关物质的结构。在所建立的条件下,头孢美唑钠及其有关物质分离良好,检测出8个有关物质,对其结构进行解析。建立的LC-MS/MS法有效地分离分析了头孢美唑钠及其有关物质,为其质量控制和工艺优化提供了技术参考。An LC-MS/MS method was established for the identification of the related substances in cefmetazole sodium.HPLC separation was carried out on an ODS column（250 mm×4.6 mm,5 μm）with a gradient elution with a mobile phase consisting of 1% formic acid aqueous solution and pure acetonitrile.80 percent of the eluent was monitored with PDA,and the rest was detected by tandem mass spectrometry.The PDA,parent ions and the corresponding product ions spectra of all the related substances in cefmetazole sodium were determined and elucidated.Good resolution of cefmetazole sodium and its main related substances was achieved.Eight related substances in cefmetazole sodium were detected by LC-MS/MS.The established method is effective in the separation and identification of the related substances in cefmetazole sodium and the results are useful for its quality control.

关 键 词：头孢美唑钠 有关物质 LC-MS/MS 分析 鉴定 

分 类 号：R927[医药卫生—药学]