The measure of amphotericin B liposomal drug concentration by HPLC

• 1、School of Life Science and Health Engineering, Jiangnan University, Wuxi 214000

Abstract：In this paper, a rapid and accurate high-performance liquid chromatography method was establishedfor the determination of liposomal drug content of amphotericin B, column: YMC-Triart-C18 ExRS (4.6 × 250 mm, 5 μm, 8 nm), mobile phase: pH=3.5 0.01 mol/L Potassium dihydrogen phosphate-methanol (volume ratio 25:75), column temperature: 25 C, flow rate: 1 mL/min, wavelength: 405 nm, injection volume: 10 μL. The retention time of amphotericin B was 11.756 min, the linearity was good in the concentration range of 4-100 μg/mL, the correlation coefficient was equal to 1, the average recoveries of low, medium and high concentrations were 96.6%, 97.1% and 97.7% respectively, the repeatability RSD of the reference and test samples was 0.88% and 0.83%, the instrument precision RSD of the reference and test samples were 0.38% and 0.32%, respectively, and the limit of quantification was 400.8 ng/mL. The content of several batches of self-made amphotericin B liposomal drugs was determined, and the actual content was within 90%-110% of the theoretical content, which is conforms to the standard of Chinese Pharmacopoeia.

Keywords： pharmaceuticalanalysis HPLC amphotericin BLiposomal