Abstract:

Background: Each film coated tablet of Amoxicillin/clavulanic acid contains 500mg of amoxicillin as an active pharmaceutical ingredient and 125mg of clavulanic acid. Different brands have the same active ingredients but different excipients, which may cause differences in efficacy since the excipients making the formulations may affect the dissolution of the drug which in turn brings the question of bioequivalence and bioavailability. The aim of this study was to determine the bioavailability equivalence of Amoxicillin among different brands of Amoxicillin/clavulanic acid tablets in Mwanza.

Methodology: In a research quality control-based laboratory analytical study was done.

Results/Discussion: According to our study, sample 01, 02, 03 and 04 after 45 minutes 105%, 108%, 107.8% and 104.9% had dissolved in the medium respectively. This showed that the tablets were of good quality since they all exceeded 85% dissolution after 45 minutes according to BP. On assay test, sample 01, 02, 03 and 04 as performed according to HPLC results were 107.6%, 93%, 101.2% and 109.3% respectively. The BP specification in 90 to 105% and an error of not more than 5% of acceptable then, all of our samples passed the test and were of good quality.

Conclusion: In our study results basing on the four samples that were used they all complied with the specification according to BP, our sample were of good quality and can be used interchangeability with equal therapeutic outcome.