Analysis of Azithromycin According to JP Method (ODP-50 4E)

Azithromycin is a 15-membered ring macrolide antibiotic.
According to the Japanese Pharmacopeia (JP; 16th edition*), analysis of arithromycin should be carried out with a column that meets following requirements. The Asahipak ODP-50 4E confirmed the requirements were met.

System suitability requirements:
   Resolution of azithromycin and 4,4'-bis(diethylamino)benzophenone (internal standard): ≥ 2.0
   Relative standard deviation (RSD): ≤ 1.0%

*The version at the time of the application acquisition.


Sample : 5 μL
1. Azithromycin 1 mg/mL
2. 4,4'-Bis(diethylamino)benzophenone 30 μg/mL

 

Column       : Shodex Asahipak ODP-50 4E (4.6 mm I.D. x 250 mm)
Eluent       : 40 mM K2HPO4 aq. (pH11.0 adjusted with potassium hydroxide aq.)/CH3CN=40/60
Flow rate    : 1.0 mL/min
Detector     : UV (215 nm)
Column temp. : 40 °C 

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