Determination of 24 elemental impurities in dizocine injection by ICP-MS
10.19778/j.chp.2024.02.008
- VernacularTitle:ICP-MS测定地佐辛注射液中24种元素杂质
- Author:
Xiaoqing HUANG
1
;
Yibo TAO
Author Information
1. 泰州市药品检验院,江苏泰州 225300
- Keywords:
dizocine injection;
ICH Q3D;
ICP-MS;
elemental impurities;
quality control
- From:
Drug Standards of China
2024;25(2):159-163
- CountryChina
- 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.
