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[Analysis of impurity in caderofloxacin]
Ren-ling Ma1, Hong-hua Zhou, Rong Liu
1Center for Instrumental Analysis, China Pharmaceutical University, Nanjing 210009, China. marenling@sohu.com
Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|March 26, 2004
Summary
The main impurity in caderofloxacin was identified as DMCA (1-cyclopropyl-8-(difluoromethoxy)-6-fluoro-1, 4-dihydro-7-(1-piperazinyl)-4-oxo-3-quinoline carboxylic acid) using RP-HPLC/ESI/MS analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Caderofloxacin is a fluoroquinolone antibiotic.
- Identifying impurities is crucial for drug safety and quality control.
Purpose of the Study:
- To identify and characterize the primary impurity present in caderofloxacin.
Main Methods:
- Reverse-phase high-performance liquid chromatography (RP-HPLC) coupled with electrospray ionization mass spectrometry (ESI-MS).
- Comparison of chromatographic and spectral data (HPLC, UV, MS) with a synthesized standard (DMCA).
Main Results:
- The impurity exhibited a molecular weight 14 units less than caderofloxacin, indicating the absence of a CH2 group.
- The retention time (tR), UV spectrum, and MS spectrum of the impurity matched those of the synthesized DMCA.
Conclusions:
- The main impurity of caderofloxacin was definitively identified as DMCA.
- The analytical methods employed (RP-HPLC/ESI/MS) proved effective for impurity profiling.