电感耦合等离子体发射光谱法检测碘海醇原料药中铜、铁、铝含量

Content Determination of Cu,Fe,Al in Iohexol Active Pharmaceutical Ingredient by Inductively Coupled Plasma-Optical Emission Spectrometry

目的建立测定碘海醇原料药中铜、铁、铝含量的电感耦合等离子体发射光谱(ICP-OES)法。方法雾化气为0.5L/min,冷却气为12 L/min,辅助气为0.5L/min,等离子体功率为1150W,蠕动泵转速为50r/min,观测模式为垂直,重复次数为3次。铜分析谱线波长为324.75nm,铁为238.20nm,铝为396.15nm。结果铜、铁、铝质量浓度在0.5～3.0μg/mL范围内与发射信号强度线性关系良好,r分别为0.9997,1.000,1.000(n=5);平均加样回收率分别为98.25%,99.34%,97.62%,RSD分别为2.20%,0.62%,0.86%(n=9)。结论 ICP-OES法适用于碘海醇原料药中铜、铁、铝含量的测定,操作简单,结果准确,灵敏度较高。

Objective To establish an inductively coupled plasma-optical emission spectrometry（ ICP-OES） method for content determination of Cu, Fe, Al in iohexol active pharmaceutical ingredient（ API）.Methods The atomization gas was 0.5L/min, the cooling gas was 12L/min,the auxiliary gas was 0.5L/min,the plasma power was 1 150 W,the rotation speed of the peristaltic pump was 50 r/min,the observation mode was vertical and the repetition number was 3 times.The wavelength of analytical spectral line of copper was324.75nm,that of iron was 238.20 nm and that of aluminum was 396.15nm.Results The linear range of Cu,Fe,Al was 0.5-3.0 μg/m L, r = 0.999 7,1.000,1.000（ n = 5）.The average recoveries were 98.25%,99.34%,97.62%, RSDs were 2.20%,0.62%,0.86%（ n = 9）.Conclusion The ICP-OES method is simple,accurate and sensitive,which is suitable for the content determination of Cu,Fe and Al in iohexol API.