Relative bioavailability of a locally manufactured ciprofloxacin tablet

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With the increasing availability of drugs, coupled with the problem of which one to choose or which one to substitute in place of the other on the Ghanaian market, a lot of controversy has been generated over the years within professionals who prescribe, dispense or purchase drugs. Thus the relative bioavailability of ciprofloxacin, a quinolone, with extensive antibacterial spectrum, currently, widely employed in Ghana was investigated for a locally manufactured brand from Phyto-Riker (GIHOC) pharmaceuticals; using ciprinol, a product of KRKA, Slovenia, as the reference. In vivo dissolution tests on these products were conducted in six healthy subjects in a cross over method and the amount of unchanged ciprofloxacin in the urine voided by these subjects over 24hour period was determined and quantified. A simple, rapid, accurate, specific and sensitive isocratic HPLC method for the detection and quantification of ciprofloxacin in human urine was developed and validated. The HPLC method designed was used for the separation and resolution of ciprofloxacin in the urine on a reversed phase column at ambient temperature with a mobile phase combination of methanol and 5% glacial acetic acid (5:95) and elution was in the isocratic mode with a UV detection at a wavelength of 275nm. Norfioxacin was used as the internal standard and the mean retention times for ciprofloxacin and norfioxacin were 2.122±0.09lmins. and 3.069 ± 0.0l7mins respectively. The quantization limit for the calibration curve used was 0.1% to 0.5%w/v. The HPLC method for assaying the two products was statistically compared to the BP method and the absolute precision of 2.27 and 8.71 respectively was obtained and their respective absolute errors were 0.92 and 0.98% respectively. No significant differences existed between the means of the two methods and no significant differences in the precision of the two methods. Pharmacokinetic parameters such as the average cumulative amount of unchanged drug excreted, the time for peak urinary excretion and the mean peak urinary excretion rate were assessed to characterize bioequivalence. The products used for the work all passed the specifications described in the BP2002. The results obtained also show that there were no significant differences in the pharmacokinetic parameters assessed for the two products and thus were said to be bioequivalent. The relative bioavailability of product T (from Phyto-Riker) was thus found to be 99.94%.
A thesis presented to the Department of Pharmaceutical Chemistry, College of Health Sciences, Kwame Nkrumah University of Science and Technology in partial fulfilment of the requirements for the award of Master of Science in Pharmaceutical Science, 2005