微波消解-ICP-MS法检测盐酸多奈哌齐原料药中10种元素杂质的含量  

Determination of ten elemental impurities in drug substance donepezil hydrochloride by ICP-MS

作　　者：戈东阳 富薪竹 赵旻[1] 张雨萌 王淼[1] 赵春杰[1] GE Dongyang;FU Xinzhu;ZHAO Min;ZHANG Yumeng;WANG Miao;ZHAO Chunjie(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Jiangsu Hansoh Pharmaceutical Group Co.Ltd.,Lianyungang 222000,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳111016 [2]江苏豪森药业集团有限公司,江苏连云港222000

出　　处：《中国药剂学杂志（网络版）》2024年第5期194-200,共7页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的建立盐酸多奈哌齐原料药中铅(Pb)、镉(Cd)、砷(As)、镍(Ni)、铬(Cr)、铜(Cu)、钼(Mo)、钯(Pd)、铁(Fe)、锰(Mn)10种元素的分析方法。方法采用微波消解法消解样品,使用电感耦合等离子质谱法同时测定盐酸多奈哌齐原料药中10种金属元素的含量。结果检测的10种元素线性关系良好,线性相关系数r>0.9990,各元素的检出限在0.5~35 ng·g^(-1),定量限在1.5~105 ng·g^(-1),回收率在88.7%~120.0%,方法重复性RSD<10%。结论该方法可用于检测盐酸多奈哌齐原料药中10种元素杂质的含量。Objective A method for the analysis of Pb,Cd,As,Ni,Cr,Cu,Mo,Pd,Fe and Mn in donepezil hydrochloride was established.Methods The contents of 10 metal elements in drug substance donepezil hydrochloride were determined by inductively coupled plasma mass spectrometry(ICP-MS)with microwave digestion method.Results The 10 metal elements showed a good linearity in the selected concentration ranges,with the correlation coefficients of the standard curves were more than 0.9990.The detection limits of the 10 elements were in the range of 0.5-35 ng·g^(-1),and quantitation limits of the 10 elements were in the range of 1.5-105 ng·g^(-1).The recoveries were 88.7%-120.0%,and RSD values of method repeatability were less than 10%.Conclusion The method can be used for the determination of 10 elemental impurities in Donepezil hydrochloride.

关 键 词：盐酸多奈哌齐原料药 电感耦合等离子质谱法 元素杂质 

分 类 号：R917[医药卫生—药物分析学]