Determination of twenty-four elemental impurities in fluphenazinedecanoate by inductively coupled plasma-mass spectrometry
10.19778/j.chp.2024.05.003
- VernacularTitle:电感耦合等离子体质谱法测定癸氟奋乃静中24种元素杂质
- Author:
Ye ZHANG
1
;
Yishu SUN
;
Xiaoxia YE
;
Xue ZHANG
;
Jian LE
;
Yongjian YANG
Author Information
1. 上海市食品药品检验研究院,国家药品监督管理局化学药品制剂质量分析重点实验室,上海 201203
- Keywords:
fluphenazinedecanoate;
element impurities;
inductively coupled plasma mass spectrometry;
organic solution;
ICH Q3D
- From:
Drug Standards of China
2024;25(5):446-451
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the simultaneous determination of elemental impurities in fluphenazinedecanoate.Methods:Sample was dissolvedwith-organic solution.With 45Sc,72Ge,115In,125Te,175Lu and 209Bi used as internal standards,an ICP-MS method was developed and established with the following conditions:RF power of 1 550 W,atomizer flow rate of 0.6 L·min-1,argon oxygen mixed auxiliary gas ratio of 30％,sampling depth of 8.0 mm,and S/C temperature of-5 ℃.Results:The linear range of each element was good within the linear range(r＞0.997),the recovery rates at low,medium and high concentrations were 84％-135％,and the limit of detection was less than 0.3 J.Ten batches of samples were tested,trace contents of chromium(Cr),arsenic(As),iridium(Ir)and mercury(Hg)were detected,and the other 20 elements were less than the limit of detection.Conclusion:The method is fast,sensitive,and accurate for screening and the quality control of elemental impurities in fluphenazinedecanoate.
