Determination of twenty-four elemental impurities in fluphenazinedecanoate by inductively coupled plasma-mass spectrometry
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.
fluphenazinedecanoateelement impuritiesinductively coupled plasma mass spectrometryorganic solutionICH Q3D
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