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.
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)
出处
《广州化工》
2025年第3期102-106,共5页
GuangZhou Chemical Industry
作者简介
崔庆玲(1989-),女,工程师,主要从事药物分析新技术与质量研究;通讯作者:周向荣(1983-),女,高级工程师,主要从事药物分析新技术与产业化。
