RP-HPLC法测定两性霉素B阴道泡腾片中主药的含量

Determination of Amphotericin B in Vaginal Effervescent Tablets by RP-HPLC

目的:建立以反相高效液相色谱法测定两性霉素B阴道泡腾片中主药含量的方法。方法:色谱柱为Kromasil C18,流动相为0.01mol·L-1磷酸二氢钾-乙腈(66∶34),检测波长为408nm,进样量为10μL,流速为1.0mL·min-1,柱温为室温。结果:两性霉素B进样量的线性范围为0.404～3.636μg(r=0.999 4);平均回收率为99.39%,RSD=0.22%(n=6)。结论:本方法操作简单、准确、易行,可用于该制剂的质量控制。

OBJECTIVE： To establish a RP- HPLC method for the content determination of amphotericin B in amphotericin B vaginal effervescent tablets. METHODS： HPLC was performed on Kromasil C18 column with the mobile phase consisted of 0.01 mol·L^-1 potassium dihydrogen - acetonitrile （66 ： 34） at a flow rate of 1.0 mL·min^-1. The detection wavelength was set at 408 nm; the sample size was 10 μL, and the column temperature was set at room temperature. RE- SULTS： The linearity of amphotericin B was good in the range of 0.404--3.636μg （r = 0.999 4） and the average recovery rate was 99.39% （RSD = 0.22%, n = 6）. CONCLUSIONS： The method is simple, accurate, feasible, and it can be used for the determination of this tablets.