Bioequivalence Assay of Different Brands of Ciprofloxacin

Abstract

B a c k g r o u n d a n d O b j e c t i v e s : Ciprofloxacin is among the three most popularly prescribed antibiotics in Nigeria with plethora of brands and branded generics, some of which are of questionable integrity. This study determined the level of pharmaceutical equivalence and by inference the bioequivalence of different commercial brands of ciprofloxacin tablets marketed in Karu area of Nasarawa State. Methods: An innovator brand and five others of ciprofloxacin hydrochloride 500mg tablets were subjected to different assays by means of UV-Vis, HPLC analysis and anti-microbial screening. Results: The results of the UV-Vis analysis showed highest peak of absorbance (0.49528), at 276nm for brand A, and 280nm for brands B, C, D, E, and F. The HPLC study indicated the retention time for brands A, B, and C as 1.781 minutes, and brand D, E, and F as 1.782 minutes. All the brands passed UV-Vis and HPLC analysis which is in line with the pure ciprofloxacin used as standard. Brand B exhibited the lowest efficacy against different strains of bacteria with 102 and 195 bacteria colonies at 3.125mg/ml, and 1.5625mg/ml concentrations compared to brand C, D, E and F with bacteria colonies in the range of 2 and, 8 to 6 and 21 at 3 . 1 2 5 m g / m l , a n d 1 . 5 6 2 5 m g / m l respectively. Conclusion and recommendations: he different brands of ciprofloxacin showed high level of pharmaceutical equivalence. The antimicrobial activity of brand B was grossly suboptimal and not acceptable. Quality assessment of ciprofloxacin may be essential to recommending the brands in therapeutic interventions.