口服补液盐散(Ⅲ)中元素杂质的研究

Determination of Elemental Impurities in Oral Rehydration Salt Powder(Ⅲ)

目的建立电感耦合等离子质谱法测定口服补液盐散(Ⅲ)中元素杂质含量。方法参照ICH Q3D元素杂质指导原则确定了口服补液盐散(Ⅲ)中潜在元素杂质,使用电感耦合等离子质谱仪测定元素杂质含量。结果在考察浓度范围内线性关系良好,各元素杂质R2均大于0.9940;各杂质回收率均在80%~120%范围内,RSD均小于15%(n=6);各元素杂质精密度RSD均小于15%。结论方法学验证表明本方法简单、可靠,可对口服补液盐散(Ⅲ)中元素杂质进行有效控制。

Objective To establish an inductively coupled plasma mass spectrometry(ICP-MS)for the determination of elemental impurities in oral rehydration salt powder(Ⅲ).Methods According to the ICH Q3D elemental impurity guidelines,the potential elemental impurities in oral rehydration salt powder(Ⅲ)were determined by ICP-MS.Results All the calibration curves of the potential elemental impurities showed good linearity(R2>0.9940)over the test concentration.The average overall recoveries of the potential elemental impurities were ranged from 80%-120%,with RSD<15%(n=6).RSDs of the precision were smaller than 15%.Conclusion This method is simple,flexible and with good repeatability,which can be used for the determination of the potential elemental impurities in oral rehydration salt powder(Ⅲ).