Physico-chemical and Metal Impurity Assessment of Some Brands of Ciprofloxacin Hydrochloride Tablets Marketed in Kano Metropolis, Nigeria

Abstract

This research was carried out to assess the quality and compare the physico-chemical equivalence of twenty samples of ciprofloxacin hydrochloride tablets marketed in Kano metropolis using standard analytical methods. The physico-chemical and chemical equivalence were assessed through the evaluation of uniformity of weight, disintegration test, friability test, assay for percentage concentration, metal impurities, pH and ionic strength. The product assay was carried out using UV/Visible spectrophotometric method while atomic absorption spectrophotometer was used to determine the possible metal impurities. All the samples complied with the official specifications for uniformity of weight, friability test while one sample failed the disintegration test of 15mins. Eighteen samples conformed to specifications 90% - 110% w/w of stated amount, one sample was above the limit, 111.66+0.57% w/w, while another sample was below the limit, 87.65+0.70 w/w. Eighteen of the samples evaluated in this study could be regarded as being physico-chemically and chemically equivalent while two samples could be regarded as substandard and fake product. All the samples have the metal impurities within official specifications except for one which has high concentration of lead.

Keywords: Ciprofloxacin tablet, counterfeit, fake drug, physic-chemical and UV Spectrophotometer