ICP-OES及ICP-MS法测定注射用头孢哌酮钠舒巴坦钠中18种元素杂质的含量  

Determination of 18 Elemental Impurities in Cefoperazone Sodium and Sulbactam Sodium for Injection by ICP-OES and ICP-MS

作　　者：崔庆玲 李硕 欧阳海清 刘万里 王绛玉 周向荣 曾环想 CUI Qingling;LI Shuo;OU YANG Haiqing;LIU Wanli;WANG Jiangyu;ZHOU Xiangrong;ZENG huanxiang(Sinopharm Zhijun(Shenzhen)Pharmaceutical Co.,Ltd.,Guangdong Shenzhen 518110,China)

机构地区：[1]国药集团致君(深圳)制药有限公司,广东深圳518110

出　　处：《广州化工》2025年第3期102-106,共5页GuangZhou Chemical Industry

摘　　要：建立电感耦合等离子体发射光谱法(ICP-OES)及电感耦合等离子体质谱法(ICP-MS)测定注射用头孢哌酮钠舒巴坦钠中18种潜在风险元素杂质的含量。采用Agilent 5800 ICP-OES和Agilent 7800 ICP-MS进行检测分析。结果显示,样品加标回收率在84%~105%(n=9),RSD在0.8%~5.4%范围内,回收率高,重现性良好。建立方法灵敏度高,专属性强,精密度好,准确度高,适用于注射用头孢哌酮钠舒巴坦钠中18种潜在风险元素杂质的含量测定。ICP-OES and ICP-MS methods were developed for the analysis of 18 elemental impurities in cefoperazone sodium and sulbactam sodium for Injection.It was detected by Agilent 5800 ICP-OES and Agilent 7800 ICP-MS.Recoveries for 18 analytes ranged from 84%to 105%,with relative standard deviations(RSD)of 0.8%to 5.4%.The recovery rate was high and the reproducibility was good.ICP-OES and ICP-MS with high sensitivity,strong specificity,good precision and high accuracy were developed to determine the contents of 18 potentially hazardous elemental impurities in cefoperazone sodium and sulbactam sodium for Injection.

关 键 词：ICP-OES ICP-MS 注射用头孢哌酮钠舒巴坦钠 元素杂质 含量测定 

分 类 号：R917[医药卫生—药物分析学]