电感耦合等离子体质谱法测定盐酸雷尼替丁注射液中的13种元素

Determination of 13 elements in ranitidine hydrochloride injection by inductively coupled plasma mass spectrometry

目的通过比较标准加入法和标准曲线法,建立注射液中多元素测定的电感耦合等离子质谱法(ICP-MS)。方法采用电感耦合等离子体质谱法的标准加入法定量,对注射液中Li、Al、Cr、Ni、Cu、Sr、Mo、Cd、Sb、Ba、Hg、Pb、As的含量进行测定。结果标准曲线法和标准加入法对13种金属元素的线性相关系数均>0.999;标准曲线法回收率为87.5%~122.2%,标准加入法的回收率为96.2%~106.3%,RSD为0.9%~8.3%,检出限为0.002μg/L~0.166μg/L。结论标准加入法具有更好的回收率和准确度,结合标准加入法的ICP-MS法可快速、准确测定注射液中13种元素。

Objective To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the determination of multiple elements in injections based on standard addition method(SAM)and standard curve method(SCM).Methods Li,Al,Cr,Ni,Cu,Sr,Mo,Cd,Sb,Ba,Hg,Pb,As in injections were determined by ICP-MS standard addition method(SAM).Results The correlative coefficients of standard curves method and standard addition method of 13 various elements were found to be more than 0.999;Standard curve method indicated unsatisfactory spiked recovery was within 87.5%-122.2%.Standard addition curve method indicated satisfactory spiked recovery range from 96.2%to 106.3%with RSD of 0.9%-8.3%,and the detection limits of the instrument were within 0.002μg/L-0.166μg/L.Conclusion The standard addition method is rapid,accurate and highly sensitive,which can provide technical support for the injection quality control.