| abstract |
The invention relates to the technical field of drug analysis, and specifically discloses a method for detecting related substances in the mother nucleus of moxifloxacin. Detect according to the following high performance liquid chromatography conditions: Column: Welch UltimateXB-Phenyl, 4.6mm*250mm, 5μm; Mobile phase A: mixed aqueous solution of tetrabutylammonium hydrogen sulfate-potassium dihydrogen phosphate, pH 1.8-2.1 ; Mobile phase B: methanol; detection wavelength 286-300nm, column temperature: 43-50°C, gradient elution. By adopting the method provided by the invention, 6,8-dimethoxy impurity, 8-ethoxy impurity, 6-methoxy-8-fluorine impurity, impurity 1, impurity M-279 five in moxifloxacin parent nucleus are realized Effective detection of various impurities, accurate qualitative and quantitative detection of impurities in the mother nucleus of moxifloxacin, thereby helping to improve the clinical safety and effectiveness of moxifloxacin products. |