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SHODEX: Analyse Azithromycin with ODP-50 4E According to USP

news | 30 July 2021
Tag: indonesia shodex

As reported in Tempo.co news (15 July 2021), The Indonesian Food and Drug Monitoring Agency or BPOM has finally granted the Emergency Use Authorization for anti-parasitic drug ivermectin as the therapeutic drug to support the Covid-19 treatment. [...] The Circular was inked by the BPOM head No. HK.02.02.1.2.07.21.281 of 2021 on the second amendment to the BPOM Decree No. HK.02.02.1.2.11.20.1126 of 2020. Besides ivermectin, the circular noted seven other therapeutic drugs for Covid-19 treatment, viz. Remdesivir, Favipiravir, Oseltamivir, Immunoglobulin, Ivermectin, Tocilizumab, Azithromycin, and Dexamethasone.

Azithromycin is a 15-membered ring macrolide antibiotic. According to the United States Pharmacopeia and the National Formulary (USP 39-NF 34**), analysis of azithromycin should be carried out with a column filled with L67 packing material and meets following requirements. The Asahipak ODP-50 4E confirmed the requirements were met.
System suitability requirements:
 Resolution of azithromycin and azaerythromycin A: ≥ 3.0
 Relative standard deviation (RSD): ≤ 1.1%
 Tailing factor of azithromycin: 0.8 to 1.5
**The version at the time of the application acquisition.

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

Source – (2021, July 15). BPOM Approves Ivermectin as Covid-19 Therapeutic Drug. Tempo.co. https://en.tempo.co/read/1483423/bpom-approves-ivermectin-as-covid-19-therapeutic-drug 

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