Jin Li, S. Yao, Li-hui Yin
Mar 18, 2022
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Journal
Current Pharmaceutical Analysis
Abstract
We systematically characterized an allergic dimer impurity in cefmenoxime hydrochloride raw material by UV, IR, HR-MS, 1D and 2D NMR for the first time. The dimer stock solution of cefmenoxime hydrochloride was obtained by degradation method. The target dimer impurity in stock solution was separated by preparative RP-HPLC, and purified by freeze-drying method. The dimer’s functional groups corresponding to the characteristic peaks of UV and IR spectra were analyzed by comparison with cefmenoxime hydrochloride and its molecular formula and mass fragmentation pattern were deduced by HR-MS. Then based on the full assignment of 1H and 13C NMR signals,the dimerized position was confirmed and its absolute configuration was identified by 1D and 2D NMR. This study provided a structural basis for the allergic study of dimer impurities in cephalosporin drugs.