Study on migration contents of twelve elements in clevidipine injectable emulsion by inductively coupled plasma mass spectrometry
- VernacularTitle: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
- Author:
Fanqin GAO
;
Renle HU
- Publication Type:Journal Article
- Keywords:
clevidipine injectable emulsion;
packaging materials;
ICP-MS;
migration contents
- From:
Chinese Journal of Biochemical Pharmaceutics
2015;(3):176-178
- CountryChina
- Language:Chinese
-
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.
