ICP-MS法检测药用辅料叔丁醇中的元素杂质含量  

Determination of the Elemental Impurities in Pharmaceutic Adjuvant tert-Butanol by ICP-MS

作　　者：臧晓红[1] 姚静静 李竞梅[1] ZANG Xiaohong;YAO Jingjing;LI Jingmei(Yangtze River Pharmaceutical Group,Taizhou 225321)

机构地区：[1]扬子江药业集团有限公司,江苏泰州225321

出　　处：《中国医药工业杂志》2024年第12期1708-1712,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了ICP-MS法测定叔丁醇中的元素杂质(Cd、Pb、As、Hg、Co、V、Ni、Li、Sb、Cu)。采用微波消解法,样品用硝酸-盐酸混合溶液消解后,以在线内标的方式消除基体干扰和仪器漂移后进行测定。结果显示,Cd、Pb、As、Hg、Co、V、Ni、Li、Sb、Cu的定量限分别为0.0288、0.1798、0.0576、0.2294、0.0153、0.0253、0.2322、1.2260、0.0219、0.1386 ng/mL,均小于限度值的5%,满足检测要求;重复性、精密度的RSD均小于20%;在限度浓度25%~300%内,10种元素杂质的线性关系良好,回收率均在90%~120%。建立的ICP-MS法方便、快捷、灵敏度高、结果准确,为叔丁醇的质量控制研究提供了技术保障。An ICP-MS method was established for the determination of elemental impurities,namely Cd,Pb,As,Hg,Co,V,Ni,Li,Sb,Cu in tert-butanol.The microwave digestion method was used,and the sample was digested with a nitric acid-hydrochloric acid mixed solution.After eliminating matrix interference and instrument drift through online internal standards,the measurement was carried out.The results showed that the quantification limits of Cd,Pb,As,Hg,Co,V,Ni,Li,Sb,and Cu were 0.0288,0.1798,0.0576,0.2294,0.0153,0.0253,0.2322,1.2260,0.0219,and 0.1386 ng/mL,respectively,all of which were less than 5%of the limit values and met the detection requirements.The RSDs of repeatability and precision were both less than 20%.Within 25%to 300%of the limit concentration range,it was linear for the ten elemental impurities,with recovery rates ranging from 90%to 120%.The established ICP-MS method is convenient,fast,highly sensitive,and accurate,which provide a technical support for the quality control research of tert-butanol.

关 键 词：叔丁醇 元素杂质 ICP-MS 

分 类 号：R917[医药卫生—药物分析学]