Comparative In Vitro Quality Evaluation of Ciprofloxacin Tablets from Drug Retail Outlets in Addis Ababa, Ethiopia

Abstract

Ciprofloxacin is a fluoroquinolone derivative having a broader spectrum of antibacterial activity against Gram-negative and Gram-positive aerobic and anaerobic organisms. It is the drug of choice for treating urinary tract infections and enteric typhoid fever. Quality assurance and evaluation of antibiotics has paramount importance to monitor the distribution of counterfeit and substandard medicines in the drug retail outlets and ensure the desired therapeutic efficacy on susceptible microorganisms. This investigation
was carried out to assess the quality of eight brands of ciprofloxacin 500 mg tablets marketed by different drug retail outlets in Addis Ababa. At the time of this sampling, most of the tablets had a shelf-life of at least two years and they were in their original packages. Identity, weight uniformity, disintegration and dissolution tests as well as assay for the content of active ingredients were performed using the methods described in the British Pharmacopoeia. Hardness and equivalence of drug release at t50% and t90% of the
different brands of ciprofloxacin tablets were also evaluated and compared. All the samples passed the identity, disintegration, and dissolution tests. Among the eight brands, ciprokin® failed the weight uniformity test. Eight of the ciprofloxacin brands examined passed the assay for content of active ingredient and also assured the minimum requirement for the test in crushing strength of the tablets. The eight brands
were found to be bio-inequivalent for their drug release compared at t50% and t90% indicating significant difference in the in vitro drug release.

Keywords: ciprofloxacin tablets, comparative study, In Vitro quality evaluation, physicochemical

Ethiopian Pharmaceutical Journal Vol. 25 (1) 2007: pp. 1-8