Abstract

Quality control assessment of four brands of norfloxacin tablets marketed in Nigeria was carried out in enzyme-free simulated intestinal fluid (SIF) and simulated gastric fluid (SGF) with the aim of selecting brands that are interchangeable. The possible in vivo bioavailabilities of the brands were predicated based on their respective dissolution efficiency (DE) and predicted availability equivalent (PAE). The results of weight uniformity test, disintegration time test and other non-pharmacopoeia tests of all brands were within the acceptable ranges. Predictions from DE indicated that the brands were all bioequivalent and therefore interchangeable with the innovator brand. The concept of dissolution efficiency (DE), in vitro dissolution studies could serve as a rapid means of comparing brands of norfloxacin tablets.

Key words: Norfloxacin, interchangeability, quality control, dissolution efficiency, predicted availability equivalent.