Details

Autor(en) / Beteiligte

• El-Gindy, Alaa
• Attia, Khalid A
• Nassar, Mohammad Wafaa
• Al Abasawi, Nasr M
• Al-Shabrawi, Maisra

Titel

Optimization and validation of a stability-indicating RP-HPLC method for determination of azithromycin and its related compounds

Ist Teil von

• Journal of AOAC International, 2011-03, Vol.94 (2), p.513

Ort / Verlag

England

Erscheinungsjahr

2011

Quelle

MEDLINE

Beschreibungen/Notizen

• A validated stability-indicating HPLC method was developed for the analysis of azithromycin (AZ) and its related compounds in raw materials, capsule, and suspension using an Xterra RP C18 column at 50 degrees C with UV detection at 215 nm. Isocratic elution was employed using the mobile phase 14 mM disodium hydrogen phosphate (pH 10.5, adjusted by 1 M NaOH)-methanol-acetonitrile-tetrahydrofuran (40.0 + 30.0 + 30.0 + 0.1, v/v/v/v). AZ and 14 of its related compounds were separated and quantified. The described method was linear over the range of 2-1800 microg/mL AZ with (r = 0.9999). The stability of AZ was studied under accelerated acidic, alkaline, and oxidative conditions. The proposed method was used to investigate the kinetics of acidic and alkaline hydrolysis process of AZ at different temperatures, and the apparent pseudo first-order rate constant, half-life, and activation energy were calculated. The major peak detected from the degradation of AZ in alkaline and acidic conditions was decladinosylazithromycine, while azithromycin N-oxide was detected from the oxidative degradation. Long-term stability studies for capsule and oral suspension were carried out. The proposed stability-indicating method was completely validated according to the U.S. Food and Drug Administration requirements.