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

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.