电感耦合等离子体质谱法测定阿托伐他汀钙片剂中1类和2A类元素的含量  

Determination of class 1 and 2A elements in Atorvastatin calcium tablets by ICP-MS

作　　者：宋立平 钱胡月 周艳梅 林妮妮 董颖 SONG Liping;QIAN Huyue;ZHOU Yanmei;LIN Nini;DONG Ying(Bejing Leadingpharm Medical Technology Development Co.,Ltd.,Beijing,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6期690-693,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用电感耦合等离子体质谱法测定阿托伐他汀钙片剂中1类和2A类元素的含量。方法采用微波消解法处理样品,电感耦合等离子体质谱法测定阿托伐他汀钙片剂中砷(As)、镉(Cd)、汞(Hg)、铅(Pb)、钒(V)、钴(Co)、镍(Ni)的含量。结果各元素的检出限为0.01~1.02μg·L^(-1),定量限为0.02~3.39μg·L^(-1),As、Cd、Hg、Pb、V、Co、Ni的线性范围分别为0~18.148、0~5.971、0~36.268、0~6.013、0~120.066、0~59.951、0~240.443μg·L^(-1),r均大于0.999,各元素的线性关系良好,回收率为92.79%~106.58%,RSD≤4.84%。阿托伐他汀钙片剂中As、Cd、Hg、Pb、V、Co、Ni的含量均符合ICH-Q3D元素杂质指导原则的要求。结论所用方法快速准确、灵敏度高、重复性好,不仅可用于阿托伐他汀钙片剂中1类和2A类元素的含量测定,还为该制剂的质量控制提供了数据支持。OBJECTIVE To determine the class 1 and 2 A elements in Atorvastatin calcium tablets(ACT) by an inductively coupled plasma mass spectrometry(ICP-MS) method.METHODS Samples were first pretreated by microwave digestion and then arsenic(As),cadmium(Cd),mercury(Hg),lead(Pb),vanadium(V),cobalt(Co) and nickel(Ni) were analyzed by ICP-MS.RESULTS The limits of detection and the limits of quantitation were between 0.01-1.02μg·L^(-1) and 0.02-3.39 μg·L^(-1)respectively.The assays were linear over the concentration range of 0-18.148 μg·L^(-1)(As),0-5.971 μg·L^(-1)(Cd),0-36.268 μg·L^(-1)(Hg),0-6.013 μg·L^(-1)(Pb),0-120.066 μg·L^(-1)(V),0-59.951 μg·L^(-1)(Co),0-240.443 μg·L^(-1)(Ni) with a correlation coefficient r>0.999.The spiked recoveries were between 92.79% and 106.58% with the RSD≤4.84%.The results indicated that the contents of As, Cd, Hg, Pb, V,Co and Ni in ACT were in conformity with the requirements of ICH-Q3 D.CONCLUSION The established method appears fast, accurate, sensitive and repeatable.This approach can be used not only for the purpose of class 1 and 2 A elements quantification in ACT,but also provide a scientific support for preparation quality control.

关 键 词：阿托伐他汀钙片剂 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]