Comparative bioavailability of two brands of norfloxacin.

ABSTRACT

Twelve adult healthy volunteers participated on two occasions in a cross-over study with an interval of 30 days. The bioavailability of norfloxacin 400 mg administered as single oral dose was compared in an Indian preparation A (Torrent) and imported preparation B (Merck Sharp and Dohme (MSD), USA). Plasma was separated from the blood and stored at -20 degrees C for analysis by High Performance Liquid Chromatography. Time taken to achieve mean peak plasma concentration (Tmax) was 2.00 +/- 0.74 hours in case of Torrent (A) and 1.70 +/- 0.49 hours in case of Merck Sharp and Dohme, USA (B). The maximum plasma concentration (Cmax) ranged from 1.60 to 2.87 ug/ml in Torrent (A) and 1.18 to 2.28 ug/ml in case of MSD (B). Area under plasma concentration curve (AUCO-12hr) was 12.70 +/- 3.2 ug/ml/hour for 'A' and 14.80 +/- 2.80 ug/ml/hr for 'B'. Elimination half life (t1/2) for Torrent (A) was 9.25 +/- 5.10 hours and for MSD (B) it was 12.05 +/- 1.05 hours. There was no significant difference in the pharmacokinetic parameters between the two brands (Student's 't' test). Increased elimination half life and large bioavailability (AUC) with both the preparations in the present study suggest the need to be cautious while treating patients with renal problems and to use lower doses in Indian population to achieve desirable kinetics of norfloxacin.