Study on the Method of Determining Sodium Chloride Content in Levofloxacin and Sodium Chloride Injection by Ion Chromatography
Objective:To establish an ion chromatography method for determining the content of sodium chloride in levofloxacin sodium chloride injection.Method:Dionex IonPacTMCS12A(250 mm×4 mm)cation exchange column was used.Protective column:Dionex InPacTM CG12A(50 mm x 4 mm).Using a 20 mmol/L methane sulfonic acid solution as the mobile phase,perform isocratic elution.Using cation suppressors and conductivity detectors for detection.Flow rate:1.0 mL/min.Column temperature:30℃.Injection volume:25 μL.Result:Sodium ions showed a good linear relationship in the range of 20～60 μg/mL,with a correlation coefficient of r=1.0.The RSD of the repeatability experiment is 0.31%.Intermediate precision RSD=0.36%.The average sample recovery rate is 98.5%.The sample remains stable within 48 hours.Changing the column temperature and flow rate within a certain range has no effect on the detection results.Conclusion:This method can accurately determine the content of sodium chloride in levofloxacin sodium chloride injection.
ion chromatographylevofloxacin and sodium chloride injectionsodium chloride
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