Quality Assessment of the Commonly Prescribed Antimicrobial Drug, Ciprofloxacin Tablets, Marketed in Tigray, Ethiopia

Abstract

An attempt was made to assess the quality and compare the physicochemical equivalence of six brands of ciprofloxacin tablets marketed in Tigray, Ethiopia. Six brands of ciprofloxacin tablets were used in the study. Identity, weight uniformity test, disintegration test, dissolution test and assay for the content of active ingredients were performed using the methods described in the British Pharmacopoeia. All the samples passed the identity, disintegration, and dissolution tests but Ciflox failed to release 80% of the drug content within 30 minutes as stipulated in the pharmacopoeia. This product therefore does not comply with the BP 2004 dissolution tolerance limits. All of the brands examined pass the assay for content of active ingredient. This work revealed that the six brands included in the study complied with the physicochemical quality parameters except Ciflox which failed to meet the pharmacopoeial specification for dissolution test. Nevertheless the six brands showed that there is significant difference in the drug release in vitro (p<0.05). To justify the specification limits of the in vitro dissolution test, an attempt should be made to establish a meaningful correlation between in vitro release characteristics and in vivo bioavailability parameters.

Keywords: Physicochemical properties; Quality; Bioequivalence; Dissolution rate; HPLC