电感耦合等离子体质谱法测定注射用氯化钠中的19种元素杂质

Determination of 19 Elemental Impurities in Sodium Chloride by ICP-MS

本文旨在建立氯化钠中19种金属元素的测定方法。根据ICH Q3D的要求鉴别出潜在元素杂质及每日允许暴露量转换浓度限度;采用电感耦合等离子质谱仪,动能歧视模式,带内标校正的标准加入法进行测定,并用软件自动完成计算。本方法的检出限范围在1~184μg/kg,加标回收率范围在86.1%~116.7%,精密度范围在0.2%~11.2%,均满足美国药典和欧洲药典对于元素杂质测试方法的要求。该方法灵敏度高,操作简便,准确度与精密度好,可用于测定氯化钠中的19种潜在元素杂质。

This paper establish a method for the determination of 19 elemental impurities in sodium chloride by ICP-MS.The potential elemental impurities were identified and permitted daily exposure concentration limit were converted according to ICH Q3D.The results were calculated by standard addition method with internal standard calibration,kinetic energy discrimination mode and ICP-MS.The tiner limits of detection range was 1~184μg/kg,the spiked recovery range was 86.1%~116.7%,the precision rage is 0.2%~11.2%.All met the elemental impurities test method requirements of USP and EP.This method is sensitive,flexible,good accuracy and precise,and can be used for the determination of 19 potential elemental impurities in sodium chloride.