Objective: To develop a method for simultaneous determination of 10 elemental impurities in cefmetazole sodium for injection according to the latest requirement of ICH Q3D. Methods: Samples were analyzed after direct dissolved and dilution by inductively coupled plasma mass spectroscopy (ICP-MS), with selenium (Se), germanium (Ge), tellurium (Te), and lutetium (Lu)as internal standards. RF power was set at 1 550 W and carrier gas was set at 1.09 L·min-1. Results: The linear relationship for all elemental impurities were good(r＞0.999), with a detection limit of 0.000 2-0.059 ng·mL-1. The average recovery rate at each concentration point was 90%~110% (n=3), and the RSD were 4%-10% (n=6). Nickel (Ni) were detected at 0.1 μg·mL-1 in 3 out of 12 batches of samples from five companies, and lithium (Li) was detected at 0.1 μg·mL-1 in 1 batche. The contents of 10 elemental impurities in cefmetazole sodium for injection from different manufacturers comply with ICH requirement. Conclusions: The established method was simple, rapid, sensitive, accurate and can be used for the quality control of elemental impurities in cefmetazole sodium for injection.
ZHANG Feng-mei, CHEN Dan-dan, GU Xiao, XU Bing-yong, WANG Jian
. A method for the determination of 10 elemental impurities in cefmetazole sodium for injection according to ICH requirement*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(8)
: 1446
-1450
.
DOI: 10.16155/j.0254-1793.2023.08.22
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