Aim: To analyse the main impurity of caderofloxacin.
Methods: The impurity of caderofloxacin was analysed and determinated by RP-HPLC/ESI/MS with a Zorbax SB-C18 (150 mm x 4.6 mm ID, 5 microns) column. The mobile phase was acetonitrile-0.5% acetic acid solution (17:83). A compound was synthesized: 1-cyclopropyl-8-(difluoromethoxy)-6-fluoro-1, 4-dihydro-7-(1-piperazinyl)-4-oxo-3-quinoline carboxylic acid (DMCA). Its HPLC chromatogram, UV and MS spectrum were compared with those of the impurity in caderofloxacin.
Results: The molecular weight of the impurity was 14 less than that of caderofloxacin. It means the impurity was a CH2-group less than caderoflixacin. The tR, UV and MS of DMCA were the same as those of the impurity in caderofloxacin.
Conclusion: Based on the tR (HPLC), UV and MS, the impurity of caderofloxacin is confirmed as DMCA.
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[Analysis of impurity in caderofloxacin].
Yao Xue Xue Bao
December 2003
Center for Instrumental Analysis, China Pharmaceutical University, Nanjing 210009, China.
Aim: To analyse the main impurity of caderofloxacin.
Methods: The impurity of caderofloxacin was analysed and determinated by RP-HPLC/ESI/MS with a Zorbax SB-C18 (150 mm x 4.6 mm ID, 5 microns) column.
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