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

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Azithromycin is a 15-membered ring macrolide antibiotic. According to USP39-NF34 method, azithromycin should be analyzed using a column packed with L67. It is necessary for the system suitability to satisfy resolution (Rs) between azithromycin and azaerythromycin of ≥ 3.0, tailing factor for azithromycin of 0.8 - 1.5 and relative standard deviation (RSD) of ≤ 1.1%. It was confirmed to satisfy all conditions when azithromycin and azaerythromycin were analyzed using Asahipak ODP-50 4E.




Sample : 10 μL
Azithromycin
Azaerythromycin A
dissolved in 6.7 g/L Dibasic potassium phosphate aq. (pH8.0 adjusted with phosphoric acid)/CH3CN=40/60


Column       : Shodex Asahipak ODP-50 4E (4.6 mm I.D. x 250 mm)
Eluent       : 6.7 g/L Dibasic potassium phosphate aq. (pH11.0 adjusted with 10 M KOH)
               /CH3CN=40/60
Flow rate    : 1.0 mL/min
Detector     : UV (210 nm)
Column temp. : 40 °C