高效液相色谱法测定阿奇霉素口服溶液的有关物质

Determination of Related Substances in Azithromycin Oral Solution by HPLC

采用高效液相色谱法测定阿奇霉素口服液(Azithromycin Oral Solution)的有关物质。采用Kroma-sil ODS(4.6 mm×250 mm,5μm)色谱柱,pH4.0的0.07 mol.L-1磷酸二氢钾-乙腈(2 1)为流动相,检测波长为228 nm。该方法灵敏度高,精密度好。本法准确可行,可作为该药的质量控制方法。

A HPLC method for the determination of related substances in Azithromycin Oral Solution was established. A Kromasil ODS （250mm × 4.6mm,5 μm） column was used with the mobile phase of Potassium phosphate monobasic（pH4.0, 0.07mol·L^-1） - acetonitrile （2 ： 1 ）at the detection wavelength of 228 nm. The method is shown to be sensitive and accurate by method sample analysis. The method is suitable for quality control of Azithromycin Oral Solution.