电感耦合等离子体质谱法测定兰索拉唑原料药中10种杂质元素

Determination of 10 Elemental Impurities in Lansoprazole API by ICP-MS

本研究建立了电感耦合等离子体质谱法(ICP-MS)同时测定兰索拉唑原料药(供注射用)中Pb、As、Cd、Hg、V、Ni、Co、Li、Cu和Sb等10种杂质元素的分析方法。采用微波消解法对样品进行前处理,以45Sc、103Rh、193Ir为内标元素,采用碰撞池模式ICP-MS法进行了测定。10种元素标准曲线的相关系数均≥0.9990,检测限为0.0077~0.6136μg/L,定量限为0.0257~2.0455μg/L。3批样品中10种元素含量均远低于各自的限量标准,且各元素低、中、高3个浓度水平的加标回收率均在75.1%~123%范围内。所建立的方法操作简便快捷、准确,可用于兰索拉唑原料药(供注射用)中元素杂质残留量检测。

A method based on inductively coupled plasma mass spectrometry(ICP-MS)was developed for the simultaneous determination of 10 impurity elements(Pb,As,Cd,Hg,V,Ni,Co,Li,Cu and Sb)in the raw material of Lansoprazole API(for injection).After microwave digestion,the samples were analyzed by collision cell-ICP-MS with 45 Sc,103 Rh,and 193 Ir as the internal standards.The correlation coefficients of the standard curves for 10 target elements were larger 0.9990.The detection limit was 0.0077-0.6136μg/L with the quantitative limit of 0.0257-2.0455μg/L.The content of these elements in three batches of Lansoprazole API(for injection)was far below their corresponding limited value,and the recovery of these elements in spiked samples was 75.1%-123%.The method is simple,rapid,accurate,and can be used for the determination of elemental impurities in Lansoprazole API(for injection).