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作 者:张玲帆[1] 王艳萍[2] 刘鑫[1] 陶卫[1] 张磊[1] 张文清[1]
机构地区:[1]华东理工大学化学与分子工程学院,上海200237 [2]安捷伦科技有限公司生命科学与化学分析部,上海200233
出 处:《分析测试学报》2012年第4期475-479,共5页Journal of Instrumental Analysis
摘 要:采用有机溶剂二甲基亚砜和水(4∶1)的混合溶剂溶解药物样品,建立了电感耦合等离子体发射光谱法(ICP-OES)直接检测药物产品中金属催化剂残留的方法。在优化实验条件下,该法能快速检测欧洲药物评审委员会(EMEA)颁布指南中的14种重金属元素;方法检出限均小于0.30 mg/kg,加标回收率在90%~115%之间;对不同前处理方法的数据结果进行了对比。实验结果表明,该法操作简单、快速、准确度高,适合大批量药物产品中多元素的快速检测。An inductively coupled plasma optical emission spectrometric(ICP-OES) method was developed for the determination of metallic impurities in pharmaceutical ingredients.The samples were directly dissolved with organic mixed solvent(DMSO∶H2O=4∶1).The conditions of instrument were optimized,and the 14 metal elements listed in EMEA guidance could be rapidly analyzed by the method.The detection limits were less than 0.30 mg/kg,and the recoveries of the 14 metal elements ranged from 90% to 115%.The data was compared with those obtained from the different treatment methods.The results showed that the method,with the advantages of simplicity,easy operation and high accuracy,was suitable for the quick determination of multi-elements in large quantities of samples.
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