ICP-AES测定碘海醇中的19种金属杂质

Determination of 19 Kind of Metal Impurities in Iohexol by ICP-AES

建立电感耦合等离子体-原子发射光谱法测定碘海醇中19种金属杂质的方法。为克服各元素之间的光谱干扰,同时保证检测灵敏度,将所有元素分为3个系统,确定合适的发射谱线和观测模式,优化等离子参数。在一定的浓度范围内,各元素谱线的发射强度与浓度均呈良好的线性关系,相关系数均大于0.9992,加标回收率为90.5%—110.7%,检出限均满足测定要求。该方法专属性好、灵敏度高、准确、快捷,可作为一种通用方法用于化学原料药中金属杂质的测定,以替代传统的重金属检查法。

The method for the determination of 19 kind of metal impurities in iohexol was established by inductively coupled plasma atomic emission spectrometry（ICP-AES）.All elements were divided into three systems in order to overcome the spectral interference between them and guarantee the sensitivity of determination.The appropriate emission lines and the observation mode of every element were determined,and the plasma parameters were optimized.The emission intensity of spectral line of each element and the concentration of every element showed a good linear relationship in certain concentration range,and the correlation coefficients were all greater than 0.9992.The recoveries were from 90.5% to 110.7%,and the detection limits all met the requirements of determination.The method has good specificity,high sensitivity,good accuracy and shortcut,and that can be used as a universal method for the determination of metal impurities in chemical bulk drugs to replace the traditional method for heavy metals detection method.