电感耦合等离子体质谱法测定布洛肾素片中的1类和2A类元素  

Determination of class 1 and 2A elements in Ibuprofen renin tablets by ICP-MS

作　　者：钱胡月 宋立平 彭燕 林妮妮 董颖 QIAN Huyue;SONG Liping;PENG Yan;LIN Nini;DONG Ying(Bejing Leadingpharm Medical Technology Development Co.,Ltd.,Bejing,100094 P.R.China)

机构地区：[1]北京新领先医药科技发展有限公司,北京100094

出　　处：《华西药学杂志》2022年第5期552-555,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的 测定布洛肾素片中1类和2A类元素的含量。方法 微波消解样品,采用电感耦合等离子体质谱法测定布洛肾素片剂中砷(As)、镉(Cd)、汞(Hg)、铅(Pb)、钒(V)、钴(Co)和镍(Ni)的含量。结果 各元素的检出限为0.01~0.37μg·L,定量限为0.02~0.25μg·L;As、Cd、Hg、Pb、V、Co、Ni的线性范围分别为0~12.051、0~4.054、0~24.149、0~4.023、0~80.594、0~40.174、0~160.905μg·L,r均大于0.999,各元素的线性关系良好;回收率为96.17%~111.79%,RSD≤3.04%。布洛肾素片剂中As、Cd、Hg、Pb、V、Co和Ni的含量均符合ICH-Q3D的要求。结论 所用方法快速准确、灵敏度高、重复性好,可用于布洛肾素片剂中1类和2A类元素的含量测定。OBJECTIVE To detect class 1 and 2 A elements in Ibuprofen renin tablets.METHODS Samples were firstly pretreated by microwave digestion and then arsenic(As),cadmium(Cd),mercury(Hg),lead(Pb),vanadium(V),cobalt(Co) and nickel(Ni) were analyzed by inductively coupled plasma mass spectrometry(ICP-MS).RESULTS The limits of detection and the limits of quantitation were between 0.01-0.37 μg·Land 0.02-0.25 μg·Lrespectively.The assays were linear over the concentration ranges of 0-12.051 μg·L(As),0-4.054 μg·L(Cd),0-24.149 μg·L(Hg),0-4.023 μg·L(Pb),0-80.594 μg·L(V),0-40.174 μg·L(Co) and 0-160.905 μg·L(Ni) with a correlation coefficient more than 0.999.The spiked recoveries were between 96.17% and 111.79% with the RSD≤3.04%.The results indicated that the contents of As, Cd, Hg, Pb, V,Co and Ni in ibuprofen renin tablets were in conformity with the requirements in ICH-Q3 D.CONCLUSION The method is fast, accurate, sensitive and repeatable.This approach can be used for the purpose of class 1 and 2 A elements quantification in Ibuprofen renin tablets.

关 键 词：布洛肾素片剂 砷 镉 汞 铅 钒 钴 镍 电感耦合等离子体质谱 微波消解 含量测定 

分 类 号：R917[医药卫生—药物分析学]