Objective: To establish a inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of 29 types of element impurities with potential risks in ropivacaine hydrochloride injection,including Cd, Pb, As, Hg, Co, V, Ni, Tl, Se, Ag, Au, Pd, Ir, Os, Rh, Ru, Pt, Li, Sb, Ba, Mo, Cu, Sn, Cr, Al, Fe, Zn, B and Si, and to investigate their compatibility. Methods: Nitric acid- hydrochloric acid-water(4∶1∶95)dilution were adopted to prepare the samples, collision mode was used to eliminate double charge interference, the content of 29 impurity elements in ropivacaine hydrochloride injection were analyzed by an ICP-MS method. Results: The detection limits of the 29 impurity elements were 0.013 8-361.1 ng·mL-1, and the spiked recoveries were in the range of 93.8%-126.0%. The contents of the 29 kinds of impurity elements in 30 batches of samples did not exceed the limits. Conclusion: This method is accurate, sensitive, simple and feasible, and can provide strong technical support for the evaluation and control of potential elemental impurities in ropivacaine hydrochloride injection.
WANG Jing-wen, XU Dai-yue, CHEN Hua, YIN Li-hui
. Determination of 29 elemental impurities in ropivacaine hydrochloride injection[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(5)
: 849
-858
.
DOI: 10.16155/j.0254-1793.2023.05.15
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