A preliminary study on quantitative detection of kanamycin in amikacin sulfate injection by ion-pair chromatography with evaporative light scat-tering detection
Objective To quantitatively detect known impurity kanamycin in amikacin sulfate injection by ion-pair chromatography with evaporative light scattering detection.Methods By optimizing chromatographic conditions,a Wa-tersXbridgeC18Column(150 mm × 4.6 mm,3.5 μm)was used for the gradient elution.The mobile phase consisted of 0.2 mol·L-1 trichloroacetic acid-methanol(90:10),the flow rate was 1.0 mL·min-1,the temperature of the drift tube was set to 50 ℃ and the pressure of nitrogen was performed at 0.30 MPa.Three manufacturers were selected for analysis of amikacin sulfate injec-tion.Results Kanamycin appeared linear relationship among 2-50 μg·mL-1,and the average recovery of the added stan-dard was 100.7％.Conclusion This method is repeatable and sensitive,providing a reference for the comprehensive estab-lishment of quality control methods for amikacin sulfate injection.
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