ICP-MS测定布洛芬混悬液中13种元素杂质  

Determination of 13 elemental impurities in ibuprofen suspension by ICP-MS

作　　者：王维婷 宋航宇 熊智灵 刘志刚 WANG Weiting;SONG Hangyu;XIONG Zhiling;LIU Zhigang(Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.,Shenzhen 518110,China)

机构地区：[1]天津中医药大学,天津301617 [2]华润三九医药股份有限公司,广东深圳518110

出　　处：《广东药科大学学报》2025年第1期20-25,共6页Journal of Guangdong Pharmaceutical University

摘　　要：目的 建立布洛芬混悬液中Cd、Pb、As、Hg、Co、V、Ni、Mo、Cu、Fe、Cr、Al、Mn 13种元素杂质的测定方法。方法 采用微波消解法处理样品,并通过电感耦合等离子体质谱(ICP-MS)法测定布洛芬混悬液中13种元素杂质的含量,并验证方法的线性、检测限与定量限、准确度和精密度。结果 13种元素线性关系良好,r均≥0.999 7;13种元素的检测限(LOD)和定量限(LOQ)分别为≤0.051 4μg/mL和0.171 5μg/mL;各元素的平均回收率在94.87%~100.69%(n=9)之间;重复性试验和中间精密度试验结果良好,各元素RSD≤0.8%和RSD≤2.4%。4批布洛芬混悬液的元素杂质含量均小于限度要求。结论 建立的方法操作简便、专属性良好、准确度高,适用于检测布洛芬混悬液中的13种元素杂质。Objective To establish a quantitative analysis method for determination of 13 elemental impurities including Cd,Pb,As,Hg,Co,V,Ni,Mo,Cu,Fe,Cr,Al and Mn in ibuprofen suspension.Methods The samples were processed through microwave digestion method,and the contents of the 13 elemental impurities in ibuprofen suspension were determined by inductively coupled plasma-mass spectrometry(ICP-MS).The linearity,detection limit and quantitative limit,accuracy and precision of the method were verified.Results The method had good specificity,and the linear relationship among the 13 elements was good(r≥0.9997).The limit of detection(LOD)and limit of quantification(LOQ)of 13 elements were≤0.0514μg/mL and 0.1715μg/mL,respectively.The average recovery of each element at different concentration points ranged from 94.87%to 100.69%(n=9).Repeatability test results were good,with RSD≤0.8%;the intermediate precision test results were good,with RSD≤2.4%.Conclusion The method is easy to operate,has good specificity and high accuracy,and is suitable for the determination of the 13 elemental impurities in ibuprofen suspension.

关 键 词：布洛芬混悬液 元素杂质 电感耦合等离子体质谱法(ICP-MS) 

分 类 号：R917[医药卫生—药物分析学]