COMPARATIVE BIOEQUIVALENCE STUDIES OF SOME SELECTED BRANDS OF CIPROFLOXACIN TABLETS MARKETED IN NIGERIA
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ABSTRACT
Comparative bioequivalence studies of six selected brands of ciprofloxacin tablets was successfully conducted. In-vitro quality control studies were carried out on six randomly selected brands of ciprofloxacin to establish identity, weight uniformity, friability, crushing strength, disintegration, dissolution and assay according to BP 2002 and 2009. Cheap, simple and available method of analysis of ciprofloxacin in saliva sample was developed by U.V Spectrophotometer with variable wavelengths. The developed method was validated based on ICH guidelines. Bioequivalence parameters (Cmax, Tmax and AUC) were evaluated on the six brands of ciprofloxacin to determine their interchangeability after a wash-out period of one week. From the result of in-vitro studies all brands passed the test indicating pharmaceutical equivalence. All the brands were found to have the labeled active ingredient as they were within the accepted range of 95-105%. The percentage recovery was within the accepted range of 95 - 105%. Calibration curve was constructed and was linear within the range of 1-6µg/ml as the correlation coefficient was 0.9889. The regression equation was y= 0.1092x + 0.2015. Distilled water was used as solvent and 277nm was found to be wavelength of maximum absorption at pH4. The developed method was found to be accurate and precise. The Cmax (µg/ml) of brands A (Reference), B, C, D, E and F were 2.83, 2.61, 2.51, 2.79, 2.67 and 2.78 respectively. Mean Tmax (hrs) of Brands A, B, C, D, E and F was 2hrs. AUC (µg/ml/hr) of Brands A, B, C, D, E and F were 14.06, 12.09, 12.095, 12.18, 11.43 and 12.38 respectively. Point estimate ratio for Cmax and AUC of Brands A and B was 92.23%and 85.99%, A and C was 88.69% and 86.02%, A and D was 98.59% and 86.62%, A and E was vii 94.35% and 80.65%, A and F was 98.23% and 88.05% respectively. Acceptable range for bioequivalence parameters is 80-125%. Based on the result from the in-vitro quality control studies, all the brands complied with the pharmacopoeial specifications. The UV Spectrophotometric method developed is simple, cheap, effective, rapid, precise and available. There was no significant difference in pharmacokinetic parameters used to assess bioequivalence. Therefore, it is concluded that the test drug product is bioequivalent to the reference brand and therefore interchangeable.
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