Objective: To establish a method for the determination of lithium(Li), vanadium(V), cobalt(Co), nickel(Ni), copper(Cu), arsenic(As), cadmium(Cd), antimony(Sb), mercury(Hg) and lead(Pb) in levofloxacin injection by inductively coupled plasma mass spectrometry (ICP-MS). Methods: Helium collision combined with kinetic energy discrimination (KED) mode was selected. The RF power was 1 550 W and the sampling depth was 5 mm, the carrier gas (Argon) flow was 1.13 L·min-1 and the auxiliary gas flow was 0.8 L·min-1. The integration time was 0.03 s and the acquisition times were 30 times. Indium(In), germanium(Ge), scandium(Sc) and bismuth(Bi) were used as internal standards. Contents of the above 10 elemental impurities were simultaneously determined according to the calibration curves by ICP-MS. Results: The response values of the above 10 elemental impurities and their mass concentrations were in good linear relationships (every correlation coefficient r was greater than 0.99). The recovery rates were in the ranges of 90% to 110%. The RSDs of repeatability were less than 6%, the limit of detection and the limit of quantification were smaller than the limit of each elemental impurity. The change of detection conditions (flow rate) in a range of 1.05 L·min-1 to 1.20 L·min-1 had no significant effect on the results of measurement. The RSD of each element in the test solution which was stored at room temperature for 3 days was less than 6%. The stability of the test solution was good. The determination results of 10 elemental impurities in Levofloxacin Injection produced by three different companies were all in conformity with the regulations. Conclusion: Analytical method validation showed that the method is accurate, exclusive, rapid, sensitive and suitable for the determination of 10 elemental impurities in Levofloxacin Injection.
ZHONG Si-wei
. Determination of 10 elemental impurities in levofloxacin injection by ICP-MS[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(11)
: 1914
-1919
.
DOI: 10.16155/j.0254-1793.2023.11.14
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