摘要
建立了电感耦合等离子体质谱(ICP-MS)测定喷昔洛韦中5种元素杂质(铁、镍、铜、锌、铅)含量的分析方法。每个元素杂质在2~100 ng/mL范围内线性关系良好,回收率在97%~106%之间。铁的检测限为0.142 ng/mL,镍的检测限为0.009 ng/mL,铜的检测限为0.025 ng/mL,锌的检测限为0.024 ng/mL,铅的检测限为0.004 ng/mL。该方法具有良好的专属性、检测灵敏度、精密度、线性和准确度,可用于喷昔洛韦中5种元素杂质(铁、镍、铜、锌、铅)的质量控制。
To establish an Inductively Coupled Plasma Mass Spectrometry(ICP-MS)method for the determination of 5 elemental impurities(Fe,Ni,Cu,Zn,Pb)in penciclovir.The calibration curve for each elemental impurity was linear in the range of 2~100 ng/mL.The recovery was between 97%and 106%.The LOD was 0.142 ng/mL,0.009 ng/mL,0.025 ng/mL,0.024 ng/mL,0.004 ng/mL for Fe,Ni,Cu,Zn,Pb,respectively.The method has good specif icity,sensitivity,precision,linearity,accuracy and can be used for quality control of 5 elemental impurities(Fe,Ni,Cu,Zn,Pb)in penciclovir.
作者
周云婷
朱晓玲
王春琴
李俊行
ZHOU Yun-ting;ZHU Xiao-ling;WANG Chun-qin;LI Jun-hang(Xinchang Food and Drug Inspection and Testing Center,Xinchang 312500,China;Zhejiang Medicine Co.,Ltd.Xinchang Pharmaceutical Factory,Xinchang 312500,China;Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China)
出处
《化工管理》
2021年第17期59-61,共3页
Chemical Engineering Management