Study on migration contents of twelve elements in clevidipine injectable emulsion by inductively coupled plasma mass spectrometry / 中国生化药物杂志

ABSTRACT

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.