Azithromycin is a 15-membered ring macrolide antibiotic. According to the Japanese Pharmacopoeia (JP XVI*), “Assay" for “Azithromycin Hydrate" should be carried out with a column filled with octadecylsilanized polyvinyl alcohol gel polymer. The Asahipak ODP-50 4E confirmed the requirements were met.

System suitability requirementsElution order (Stadandard solution): azithromycin, the internal standard (4,4'-bis(diethylamino)benzophenone)
Resolution between azithromycin and the internal standard (Stadandard solution): ≥ 2.0
Relative standard deviation (RSD) of the ratios of the peak area of azithromycin to that of the internal standard (Stadandard solution): ≤ 1.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 5 µL
(Standard solution) 1 mg/mL of Azithromycin and 30 μg/mL of 4,4'-Bis(diethylamino)benzophenone (prepared according to JP method)

1. 1.Azithromycin
2. 2.4,4'-Bis(diethylamino)benzophenone