电感耦合等离子体质谱法测定油酸钠中24 种元素杂质  

Determination of Twenty-four Elemental Impurities in Sodium Oleate by ICP-MS

作　　者：孙逸舒 张叶 陈阳 乐健 SUN Yishu;ZHANG Ye;CHEN Yang;LE Jian(NMPA Key Lab.for Quality Analysis of Chemical Drug Preparations,Shanghai Institute for Food and Drug Control,Shanghai 201203;School of Pharmacy,Fudan University,Shanghai 201203)

机构地区：[1]上海市食品药品检验研究院,国家药品监督管理局化学药品制剂质量分析重点实验室,上海201203 [2]复旦大学药学院,上海201203

出　　处：《中国医药工业杂志》2024年第10期1414-1418,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了微波消解-电感耦合等离子体质谱(ICP-MS)法用于同时测定油酸钠中的24种元素杂质。结果显示,24种元素在相应质量浓度范围内线性关系良好(r>0.9970),平均回收率(n=9)均在87.04%~114.7%,RSD均小于9.8%。对来自4个厂家的18批油酸钠样品进行测定,其中某一厂家的3批样品中的Ni元素含量接近或超过控制阈值,其余23种元素均远小于控制阈值。建立的方法灵敏度高、准确度好,可用于油酸钠中24种元素杂质的痕量控制。A microwave digestion-inductively coupled plasma mass spectrometry(ICP-MS)method was established for the simultaneous determination of twenty-four elemental impurities in sodium oleate.The results showed that it was linear for twenty-four elemental impurities in the corresponding mass concentration ranges(r>0.9970).The average recoveries(n=9)were 87.04%-114.7%,with the RSDs of less than 9.8%.The eighteen batches of sodium oleate samples from four manufacturers were tested,and the Ni element contents in three batches of samples from one manufacturer were close to or exceed its control threshold,while the remaining twenty-three elements were far below the control threshold.The established method has high sensitivity and good accuracy,which can be used for trace control of twenty-four elemental impurities in sodium oleate.

关 键 词：油酸钠 ICP-MS 微波消解 元素杂质 

分 类 号：R917[医药卫生—药物分析学]