电感耦合等离子体质谱法测定碳酸锂原料药中6种元素杂质  

Determination of Six Kinds of Elemental Impurities in Lithium Carbonate API by Using Inductively Coupled Plasma Mass Spectrometry

作　　者：朱婧 宿亮 朱跃芳 左瑾蓉 赵静芝 王玲兰 Zhu Jing;Su Liang;Zhu Yuefang;Zuo Jinrong;Zhao Jingzhi;Wang Linglan(Zhuzhou Qianjin Pharmaceutical Co.Ltd.,Zhuzhou 412000,China;Institute for Food and Drug Control in Zhuzhou,Zhuzhou 412000,China)

机构地区：[1]株洲千金药业股份有限公司,株洲412000 [2]株洲市食品药品检验所,株洲412000

出　　处：《中国药事》2023年第4期414-419,共6页Chinese Pharmaceutical Affairs

基　　金：湖南省自然科学基金资助项目(编号2017JJ2123)。

摘　　要：目的:建立电感耦合等离子体质谱法(ICP-MS)测定碳酸锂原料药中汞、铅、镉、钴、镍、钒6种元素杂质含量以更好地控制药品质量。方法:样品经1%硝酸溶液直接溶解,以^(115)In、^(209)Bi为内标,采用ICP-MS测定碳酸锂中元素杂质含量。结果:6种元素在各自浓度范围内线性关系良好(r>0.990),最大检测限和定量限分别为0.40 mg·kg^(-1)、1.40 mg·kg^(-1)。平均加标回收率为92.16%~112.87%,重复性RSD为1.28%~6.63%(n=6)。结论:本方法前处理简单、检出限低、准确度高、精密度好,可用于碳酸锂中元素杂质研究和控制。Objective:To establish an inductively coupled plasma mass spectrometry(ICP-MS)method for the determination of mercury(Hg),lead(Pb),cadmium(Cd),cobalt(Co),nickel(Ni)and vanadium(V)in lithium carbonate API to better control the quality of drugs.Methods:The sample was directly solubilized in 1% nitric acid solution and the elemental impurities were determined by ICP-MS with 115In and 209Bi as internal standards.Results:The six elements showed good linear correlations within the respective concentration ranges(r>0.990)with a maximum detection limit of 0.40 mg·kg^(-1) and a maximum quantitation limit of 1.40 mg·kg^(-1) respectively.The average spiked recoveries for six elemental impurities were in the range of 92.16%-112.87%.The repeatability relative standard deviations were 1.28%-6.63%(n=6).Conclusion:The method has simple pretreatment,low detection limit,high accuracy and good precision,and can be used for the study and control of elemental impurities in lithium carbonate.

关 键 词：电感耦合等离子体质谱 碳酸锂 抗躁狂药 元素杂质 质量控制 

分 类 号：R917[医药卫生—药物分析学]