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。方法:采用Kromasil ODS(4.6 mm×250 mm,5μm)色谱柱,pH 4.0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。结果:该方法灵敏度高,精密度好。结论: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. Methods： An Kromasil ODS （250mm×4.6mm,5μm） 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. Results： The method is shown to be sensitive and accurate by method sample analysis. Conclusion：The method is suitable for quality control of Azithromycin Oral Solution.