How to Cite
Abstract
Was studied in vitro bioequivalence of Ofloxacin tablets (200 mg, Borisovo Ltd,Belarus) with the reference preparation Ofloxin (200 mg, Zentiva Ltd, Czech Republic), using a dissolution test and comparing the dissolution profiles. The data of the research show that both the reference and the study drug correspond to the requirements of USP and consequently, they are pharmaceutically equivalent. The results received during validation of the dissolution test at pH 4.5 and pH 6.8, have shown full conformity of the developed method to requirements Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 on the following validation characteristics: Specificity, Precision, Linearity and Accuracy. A comparison of the dissolution profiles of the tablets of Ofloxin and Ofloxacin shows that there is no statistically significant difference in dissolution kinetics between them and, consequently, they are equivalent in vitro.
References
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