Abstract

Six brands of ciprofloxacin 500 mg tablets have been evaluated using some quality control tests of uniformity of weight, hardness, friability, assay, disintegration and dissolution with the aim to assess its bioequivalence. The results obtained have been discussed in some details using monographs in the two Pharmacopeia (United States Pharmacopeia, USP and British Pharmacopeia, BP). The results were also subjected to statistical analysis. In particular, the dissolution test results were subjected to further tests to determine significance of ANOVA, significance of Dunnett’s test, dissolution efficiency, difference factor (f₁) and similarity factor (f₂). Subsequently the results indicated that 3 of the 6 (50%) brands may not be used interchangeably with the chosen ‘innovator’ brand.

Key words: Quality control tests, bioequivalence, ciprofloxacin, dissolution, dissolution efficiency, weight variation, disintegration.