Simultaneous Determination of Kanamycin and Kanamycin B in Kanamycin Sulfate Injection by HPLC-CAD / 中国药师

ABSTRACT

Objective: To establish an HPLC with charge aerosol detection (HPLC-CAD) method for the determination of kanamy-cin and kanamycin B in kanamycin sulfate injection. Methods: The samples were injected into a Boston Green ODS C18(250 mm× 4. 6 mm, 5 μm) column. The mobile phase was composed of 0. 2 mol·L-1trifluoroacetic acid aqueous solution-methanol (95 5) , the flow rate was 1. 0 ml·min-1and the column temperature was maintained at 30 ℃. The nebulization temperature for the CAD was maintained at 55℃ and the gas pressure was 56. 4 psi. Results: The linear range of kanamycin was 0. 385-38. 500 μg·ml-1( r=0. 999 9), and the limit of detection was 0. 075μg·ml-1, the limit of quantitation was 0. 154 μg·ml-1, and the average recovery of the method was 100. 97% (n=9). The linear range of kanamycin B was 0. 374-37. 400 μg·ml-1(r=1. 000 0), and the limit of de-tection was 0. 075μg·ml-1, the limit of quantitation was 0. 150 μg·ml-1, and the average recovery of the method was 100. 44% (n=9). Conclusion: The method for the determination of kanamycin and kanamycin B by HPLC-CAD is simple and accurate, the limit of detection is lower than HPLC-ELSD, and the quality of kanamycin sulfate injection can be effectively controlled.