Profil Disolusi in Vitro Tablet Levofloksasin Generik Dan Levofloksasin Non Generik

Levofloxacine is an antibiotic broad spectrum of quinolon. It has been used to treat bacterial infections in respiratory tract, urinary tract, and skin. Till in this time Levofloxacine no in monograph in USP, hence not yet owned definitive dissolution method. The in vitro dissolution testing very important to ensure quality of drug product with show that drug release in this solvent and to the prediction of in vivo performance. This research was proposed to compare dissolution profile Levofloxacine tablet in HCl 0.1 N medium and Phosphat buffer of pH 7.4, and also to compare profile dissolution of generic Levofloxacine with non generic one. In the dissolution testing used paddle methode. Medium was 900 ml of HCl 0.1 N and Phosphat buffer of pH 7.4 at 37± 0.5°C with a speed 50 rpm. Sample aliquots (5 mL) were withdrawn at 5, 10, 20, 30 and 45 minutes and replaced with equal volumes of fresh medium. Sample was absorbed with spectrophotometrically at λ max. The results of dissolution showed that the drug concenrations of Levofloxacine reaching more than 80% is released over 45 minutes. Dissolution profile of Levofloxacine in HCl 0.1 N medium better than Levofloxacine in Phosphat buffer of pH 7.4 medium and no significantly differences between generic Levofloxacine with non generic Levofloxacine. Key words : dissolution profile, in vitro, levofloxacine