Журнал хроматографии и методов разделения
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Validated Stability-indicating HPLC and Thin Layer Densitometric Methods for the Determination of Pazufloxacin: Application to Pharmaceutical Formulation and Degradation Kinetics

Nehad A Abdallah

Two stability indicating methods were developed for the determination of pazufloxacin in presence of its acidic and alkaline degradation products, in pure form and in IV injection. The first method was based on RP-HPLC on X-terra C18 column (25 cm×4.6 mm×5 μm) using methanol and 0.5% phosphoric acid (15:85 (v/v)) with the addition of 1% Triethylamine (TEA) as a mobile phase over a concentration range 2-40 μg ml-1 and a mean percentage recovery of 100.467 ± 0.595. Quantification was achieved with UV detection at 249 nm. The second method was based on TLC separation of pazufloxacin from its degradation products followed by Densitometric measurement of the intact drug spot at 249 nm. The separation was carried out on silica gel 60 F254 aluminum sheets using chloroform, methanol and ammonia (10: 8: 2 v/v/v), as the mobile phase over a concentration range 0.1-2 μg per spot and mean percentage recovery of 99.694 ± 0.539. The two methods were simple, precise, and sensitive that could be successfully applied for the determination of pure and intravenous (IV) injection. The proposed HPLC method was used for the determination of acidic and alkaline degradation kinetics of pazufloxacin. The apparent first-order rate constants, half-life times, and activation energies of the degradation processes were calculated.