In vitro quality evaluation of generic ciprofloxacin tablets available in community pharmacies of Dessie town, Northeast Ethiopia

Abstract

The introduction of generic drug products from multiple sources into the health care system of many developing countries may lead to spread of substandard medicines. Post marketing surveillance is very crucial to ensure product quality and eliminate substandard medicines and consequently, ensure better patient clinical outcome. Hence, the aim of the present work was to assess the quality of six generic ciprofloxacin hydrochloride 500 mg tablets available in Dessie town, Northeast Ethiopia using in vitro quality control tests. Weight variation test, disintegration test, dissolution test and assay for the content of active ingredients were done as per the United States pharmacopoeia. All generic ciprofloxacin hydrochloride tablets were evaluated for conformity with United States Pharmacopoeial standards.The results of weight variation test indicated that all samples were complied with United States Pharmacopoeial specifications.The percentage content of generic ciprofloxacin tablets was within the range of 90–110% and the disintegration time was found between 2.375 and 6.31 min. In addition, generic ciprofloxacin tablets released more than 80% of the drug in 30 min. Hence, all generic ciprofloxacin tablets met the quality control parameters as per the United States pharmacopoeial specifications.