Aim: To analyse the impurities of gatifloxacin.
Methods: The impurity of gatifloxacin were analysized and determinated by RP-HPLC/electrospray ionization mass spectrometry with a Zorbax SB-C18(4.6 mm x 150 mm ID, 5 microns). The mobile phase was 3% acetic acid/acetonitrile-3% acetic acid/water (15:85). The two compounds were synthesized: 1-cyclopropyl-6-fluoro-1, 4-dihydro-8-methoxy-7-(1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid (DMP) and 1-cyclopropyl-6-fluoro-1, 4-dihydro-8-hydro-7-(3-methy-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid (DMO). Their liquid chromatogram, UV, MS were compared with those of the impurity of gatifloxacin.
Results: The mass of the impurity was 14 less than that of gatifloxacin. It means the impurity was CH2 less than gatifloxacin. The tR (HPLC), UV and MS of DMP were the same as those of the impurity of gatifloxacin.
Conclusion: Based on the tR (HPLC), UV and MS, the impurity of gatifloxacin is confirmed as DMP.
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HPLC has become the most important analytical technique for impurity profiling in order to assure the quality of pharmaceutical products. Although HPLC is considered as a well-established technology, it requires CRS (chemical reference substances) of impurities for qualification and quantification of impurity peaks. Many impurity CRS have been widely used for the impurity profile control, which causes a high cost of production in practice.
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Aim: To analyse the impurities of gatifloxacin.
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