Drug Standards of China 2024;25(2):159-163
doi:10.19778/j.chp.2024.02.008
Determination of 24 elemental impurities in dizocine injection by ICP-MS
Xiaoqing HUANG 1 ; Yibo TAO
Affiliations
Keywords
dizocine injection; ICH Q3D; ICP-MS; elemental impurities; quality control
Country
China
Language
Chinese
Abstract
Objective:To establish a method of inductively coupled plasma mass spectrometry(ICP-MS)for the simultaneous determination of 24 elemental impurities in dizocine injection in accordance with the relevant regula-tions of ICH Q3D.Methods:ICP-MS method was adopted to analyze the sample solutions after being diluted and then corrected by spiking indium and bismuth as internal standards,the plasma output power was set at 1 550 W,the sampling depth was set at 5 mm,the maximum load volume was set at 1.038 L·min-1,the cooling gas was set at 14 L·min-1,the auxiliary gas was 0.8 L·min-1,the peristaltic pump speed was 40 r·min-1,the injection system was hydrofluoric acid resistant system,the sampling cone and the pattern of the intercept cone were nickel cone and the sampling mode was manual and repeated 3 times.Results:All 24 elements were linear(all r were more than 0.99),the average recoveries were between 80.46%and 102.95%,the repeatability were less than 10.88%,and the intermediate precision were not more than 6.49%.The results of 24 elemental impurities in 3 different batches of dizocine injection met requirements of ICH Q3D.Conclusion:The ICP-MS method is conven-ient,rapid,sensitive and accurate,and can be used to detect the concentrations of 24 metal elements in dizocine injection,which may provide a basis for more strict quality management of the injection.
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