BIOEQUIVALENCE EVALUATION OF NORFLOXACIN TABLETS BASED ON IN VITRO – IN VIVO CORRELATION

Present study was designed to establish in-vitro and in-vivo correlation (ivivc) of two immediate release tablet formulations of 400mg norfloxacin [drug a as test and drug b as reference]. dissolution study was conducted in 0.1 n hcl using usp apparatus ii. in-vivo evaluation was carried out in 18 healthy humans according to a single dose, two-sequence, and cross-over randomized with a wash-out period of one week. after dosing, serial blood samples were collected for a period of 10 hours. plasma harvested from blood, was analyzed for norfloxacin by a sensitive, reproducible and accurate hplc method. various pharmacokinetic parameters were determined from plasma concentrations for both the formulations. non-significant difference was found for test/reference ratio of these parameters and the value of f was found to be 0.99 which is in good agreement with the limits given in fda and who guidelines for such parameters. difference factor (f1), similarity factor (f2) and level a ivivc were evaluated showing that drug a is bioequivalent to drug b.