抗癌新药拉洛他赛原料药中锂元素残留量测定  

Determination of Lithium Element Residues in Raw Materials of New Anticancer Drug Larotaxel

作　　者：王红芳 宋小飞 王潞娜 聂磊 张辉 WANG Hong-fang;SONG Xiao-fei;WANG Lu-na;NIE Lei;ZHANG Hui(Shanxi Zhendong Pharmaceutiacal Co.,Ltd.,Shanxi Changzhi 046000,China)

机构地区：[1]山西振东制药股份有限公司,山西长治046000

出　　处：《广州化工》2023年第15期84-87,共4页GuangZhou Chemical Industry

摘　　要：建立电感耦合等离子体质谱法测定拉洛他赛中锂元素残留量的方法。采用微波消解法进行样品前处理,以钪作为内标元素,采用在线引入内标测定锂元素残留量。锂元素质量浓度在0~500 ng·mL^(-1)范围内,线性相关系数为0.9999,检测限为2.766 ng·mL^(-1),定量限为9.221 ng·mL^(-1),加标重复性试验的RSD为2.5%,加标回收率在95.6%~104.2%范围内,相对标准偏差为2.8%(n=9)。本方法操作简单、准确、重复性好,可用于拉洛他赛中锂元素残留量的测定。A method for the determination of lithium residues in larotaxel by inductively coupled plasma mass spectrometry was established.Microwave digestion was used for sample pretreatment,scandium was used as the internal standard element,and the internal standard was introduced online to determine the residual amount of lithium element.The mass concentration of lithium was in the range of 0~500 ng·mL^(-1),the linear correlation coefficient was 0.9999,the detection limit was 2.766 ng·mL^(-1),and the quantification limit was 9.221 ng·mL^(-1).RSD of the standard addition repeatability test was 2.5%,and the standard addition recovery rate was in the range of 95.6%to 104.2%,and the relative standard deviation was 2.8%(n=9).The method was simple,accurate and repeatable,and could be used for the determination of the residual amount of lithium in larotaxel.

关 键 词：电感耦合等离子体质谱仪(ICP-MS) 微波消解 拉洛他赛 锂元素 

分 类 号：R917[医药卫生—药物分析学]