Objective: To develop a inductively coupled plasma-mass spectrometry(ICP-MS)method for 7 kinds of elemental impurities(Pb,As,Hg,Cd,Cr,Ni and Zn)in ferrous fumarate, and evaluate the ferrous fumarate quality. Methods: The ICP-MS method was established for the simultaneous determination of elemental impurities including Pb, As, Hg, Cd, Cr, Ni, and Zn in ferrous fumarate using Sc, Rh and Lu as the internal standards. Results: The ICP-MS calibration curves for Pb, As, Cd, Cr, Ni, Zn were all linear in the ranges of 1-1 000 ng·mL-1, while that for Hg was in the concentration range of 0.025-5 ng·mL-1. All the correlation coefficients were not less than 0.999. The recoveries were between 93.0% and 105.4%(n=3) for all the tested elements. The limits of detection were 0.1, 0.03, 0.005, 0.03, 0.03, 0.5, 0.3 ng·mL-1 for Pb, As, Hg, Cd, Cr, Ni and Zn, respectively. Conclusion: The newly established ICP-MS method for the simultaneous determination of various elemental impurities contained in ferrous fumarate is selective, sensitive and robust. The established method can meet the elemental impurities test requirement and be employed for ferrous fumarate quality monitoring and evaluation to ensure the medication safety.
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