Objective  To establish a inductively coupled plasma-mass spectrometry (ICP-MS) method for 7 elemental impurities, cadmium (Cd), lead (Pb), arsenic (As), mercury (Hg), cobalt (Co), vanadium (V) and nickel (Ni) in medicinal excipient potassium sorbate according to the latest requirement of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D.

Methods  After dissolving the sample with 2% nitric acid solution, the potassium sorbate sample was digested by closed ultra-high pressure microwave digestion technology, and the elements rhenium (Re), rhodium (Rh), germanium (Ge), scandium (Sc) and bismuth (Bi) were used as internal standards to correct the matrix interference and drift.

Results  The 7 elements showed good linearity in the specified concentration range (r>0.998 0). The detection limits were between 0.002-0.042 ng/g, the recovery rates were between 85%-106%, and the RSDs of each element precision were ≤5%. The content of elemental impurities in 13 batches of domestic and imported potassium sorbate samples from different manufacturers was determined legally, and none exceeded the limit, which was in line with the provisions of ICH.

Conclusion  The established method is simple, accurate, sensitive, specific and reproducible. In this test, the elemental impurity residues in potassium sorbate are screened, which can not only grasp the overall quality level of potassium sorbate, but also ensure the safety of potassium sorbate as medicinal excipients, and provides a methodological basis for the revision of the Chinese Pharmacopoeia.

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