两性霉素B阴道泡腾片有关物质液相色谱方法的建立

Establishment of the related substances for Determination of Amphotericin B Vaginal Effervescent Tablets by HPLC

目的:建立以液相色谱方法测定两性霉素B阴道泡腾片有关物质的方法。方法:色谱柱为Diamonsil^(TM)(钻石)C_(18)(4.6mm×250mm,5μm)C_(18),流动相为0.005mol/L EDTA-Na_2溶液-甲醇(3:7),流速为1.0ml/min,柱温:35℃,检测波长为380nm。结果:在上述色谱条件下,各成分得到有效分离,空白辅料无干扰。结论:该方法专属性强,灵敏度高、系统耐用性好,可以作为两性霉素B阴道泡腾片的有关物质检测方法。

Objective： To establish a HPLC method for determination of the related substances in Amphotericin B Vaginal Effervescem Tablets. Method： The determination Was per - formed by HPLC with the DiarnonsirIM C18 column （4.6mm ×250mm, 5μm） under 35℃, 0. 005mol/L EDTA- 2Na - methanol（3： 7）was taken as the mobile phase with the flow rate at 1.0ml/min and the detection wavelength set at 380nm. Results： Under The chrcmatography conditions, the component can be separated . the blank experiments have no interference, specific. Conclusion： The method is phase and accurate with good reproducibility, can be used for the determination of the related substances in Amphotericin B Vaginal Effervescent Tablets.