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微波消解-电感耦合等离子体质谱法测定盐酸氯哌丁原料药中的重金属元素

钟振华,王鹏,程奇珍   

  1. 江西省药品检验检测研究院,江西省药品检验检测研究院,江西省药品检验检测研究院
  • 收稿日期:2018-03-01 修回日期:2018-03-01 出版日期:2018-06-25 发布日期:2018-06-25

Determination of Heavy Metals in Cloperastine Hydrochloride by Microwave Digestion-Inductively Coupled Plasma Mass Spectrometry

zhong zhen hua, and   

  1. Jiang Xi Institute For Drug Control,,
  • Received:2018-03-01 Revised:2018-03-01 Online:2018-06-25 Published:2018-06-25

摘要: 目的:建立测定盐酸氯哌丁原料药中铬(Cr)、锰(Mn)、钴(Co)、镍(Ni)、铜(Cu)、锌(Zn)、砷(As)、银(Ag)、镉(Cd)、钡(Ba)、汞(Hg)、铊(Tl)、铅(Pb)等重金属元素含量的方法。方法:样品加入硝酸经微波消解处理,采用电感耦合等离子体质谱法以7Li、45Sc、72Ge、115In为内标元素测定该13种金属元素。结果:测定的13种重金属元素标准曲线的相关系数均大于0.999;5批次样品13种重金属元素含量均在安全范围内。结论:该方法线性回归良好、灵敏度高、准确性好,适用于盐酸氯哌丁原料药中重金属元素的检测分析。

Abstract: Objective: To establish a method for the contents determination of Cr、Mn、Co、Ni、Cu、Zn、As、Ag、Cd、Ba、Hg、Tl、Pb in Cloperastine Hydrochloride. Methods:After digested by microwave digestion,The Heavy metals were determined by inductively coupled plasma mass spectrometry (ICP MS) with 7Li, 45Sc, 72Ge and 115In as internal standard elements. Results: About the measured elements,of correlation coefficient r of the calibration curve were greater than 0.999. The contents of 13 kinds of heavy metals in 5 batch samples were all within the safe range. Conclusion: The method with good linear ralationship, sensitivity and accuracy, suitable for detection of trace heavy metals in the analysis of Cloperastine Hydrochloride.