ICP-MS测定丁酸氯维地平脂肪乳注射液中12种元素的迁移量研究

Study on migration contents of twelve elements in clevidipine injectable emulsion by inductively coupled plasma mass spectrometry

目的：建立电感耦合等离子体质谱（ inductively coupled plasma mass spectrometry，ICP－MS）法并测定丁酸氯维地平脂肪乳注射液的包装材料向注射液中12种元素的迁移量。方法碳化－氧化法消解，采用内标法，建立ICP－MS方法测定丁酸氯维地平脂肪乳注射液中12种元素的迁移量。结果各元素线性关系良好（ r＞0．9995），方法准确度、精确度和稳定性均达到要求。加标回收率分别在81．3％～119．0％之间。结论所选择的包装材料与丁酸氯维地平脂肪乳注射液具有较好的相容性，其向注射液中迁移的元素有Na、K、Sb和Ba，迁移量符合要求。

Objective To establish inductively coupled plasma mass spectrometry（ICP-MS） method and determine the migration contents of twelve elements in clevidipine injectable emulsion direct contact with packaging materials.Methods Clevidipine injectable emulsion were digested by carbonization-oxidation.Based on internal standard method, migration contents of twelve elements in digested sample solutions were analyzed by ICP-MS.Results The linear correlative coefficients for twelve elements were higher than 0.9995.The accuracy, precision and stability of the method were detected, all of which conformed to the analysis standard.The recoveries were in the range of 81.3%~119.0%.Conclusion The packaging materials have good compatibility with injectable emulsion, and migration contents of Na、K、Sb and Ba of twelve elements meet the requirements.