摘要
目的建立注射用亚胺培南西司他丁钠中24种杂质元素含量的测定方法。方法样品用去离子水经超声溶解、用硝酸酸化后,采用电感耦合等离子体质谱仪(ICP-MS)内标法测定杂质元素含量。结果各元素线性关系良好,相关系数(r)均大于0.995,方法检出限为0.0004~0.048μg·g^(-1),回收率在73.0%~130.4%之间,相对标准偏差RSD为0.5%~20.2%(n=18)。结论该方法准确、便捷、灵敏,可用于亚胺培南西司他丁钠中杂质元素含量的测定。
OBJECTIVE To estabulish a method for determination of 24 impurity elements in imipenem and cilastatin sodium for injection.METHODS After the samples were dissolved by deionized water and treated with ultrasonic cleaner,added nitric acid for acidification,24 elements were determined by inductively coupled plasma-mass spectrometer(ICP-MS).RESULTS The linearity of each element was good and the correlation coefficient was over 0.995.The detection limits of the method were in the range of 0.0004-0.048μg·g^(-1).The recovery was 73.0%-130.4%,RSD was between 0.5%-20.2%(n=18).CONCLUSION The method is accurate,simple and sensitive,and can be used for the determination of impurity elements in imipenem and cilastatin sodium for injection.
作者
刘健
廖佳
陈巧兰
卓灏
梁玉英
LIU Jian;LIAO Jia;CHEN Qiaolan;ZHUO Hao;LIANG Yuying(Technical Centre of Gongbei Customs District,Zhuhai,Guangdong 519015,China;Zhuhai Labfy Technical Services Co.,Ltd,Zhuhai,Guangdong 519015,China)
出处
《今日药学》
CAS
2021年第3期182-186,共5页
Pharmacy Today
基金
珠海进出口公共技术服务平台产学研协同创新计划项目(IETP201901012)。
