Abstract
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.
Highlights
Pazufloxacin(-)-(S)-10-(1-aminocyclopropyl)-9-fluoro-3-methyl7-oxo-2,3-dihydro-7Hpyrido[2,3-de][1,4]benzoxazine-6-carboxylic acid monomethanesulfonate, figure 1 is a fluoroquinolone synthesized by Toyama Chemical Co
One of the previous methods was used as a stability indicating method for the determination of pazufloxacin in pharmaceutical formulation and in presence of its degradation products [19]
This method was of low sensitivity (10 μg ml-1) and lacks either the study of degradation kinetics of pazufloxacin or the identification of the degradation products
Summary
Pazufloxacin(-)-(S)-10-(1-aminocyclopropyl)-9-fluoro-3-methyl7-oxo-2,3-dihydro-7Hpyrido[2,3-de][1,4]benzoxazine-6-carboxylic acid monomethanesulfonate, figure 1 is a fluoroquinolone synthesized by Toyama Chemical Co. Reviewing the literature revealed that, few methods have been reported for the determination of pazufloxacin in raw material, pharmaceutical formulation and/or human plasma. One of the previous methods was used as a stability indicating method for the determination of pazufloxacin in pharmaceutical formulation and in presence of its degradation products [19]. The aim of the present work is to focus on the development of efficient chromatographic methods for the determination of pazufloxacin in IV injection without interference from the excipients used and in the presence of its different degradation products in a short chromatographic run, and to study the results kinetically to prove the stability-indicating property of the method. The developed densitometric TLC system can further be used in the future to separate the degradation products for their structural elucidation trying to identify the degradation pathway
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