Determination of element impurities in medicinal excipient potassium sorbate by ICP-MS
10.12173/j.issn.1008-049X.202402056
- VernacularTitle:电感耦合等离子体-质谱法测定药用辅料山梨酸钾中元素杂质残留量
- Author:
Sai PANG
1
;
Kun JIANG
;
Ping WANG
Author Information
1. 深圳市药品检验研究院(广东深圳 518057);深圳市药品质量标准研究重点实验室(广东深圳 518057)
- Keywords:
Potassium sorbate;
Medicinal excipient;
Inductively coupled plasma-mass spectrometry;
Element impurities;
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q3D
- From:
China Pharmacist
2024;27(8):1303-1308
- CountryChina
- Language:Chinese
-
Abstract:
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.
