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)

作　　者：史大勇 郭伟 颜世强 李亮亮 解春文 SHI Da-yong;GUO Wei;YAN Shi-qiang;LI Liang-liang;XIE Chun-wen(Shandong Dayin Marine Biopharmaceutical Co.,Ltd.,Weihai 264300,China)

机构地区：[1]山东达因海洋生物制药股份有限公司,山东威海264300

出　　处：《食品与药品》2023年第5期396-399,共4页Food and Drug

基　　金：山东省自然科学基金(编号:ZR2021QH358)。

摘　　要：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).

关 键 词：ICH Q3D 元素杂质 口服补液盐散(Ⅲ) 

分 类 号：R927.1[医药卫生—药学]