title: Bioequivalence evaluation of norfloxacin tablets based on in vitro - in vivo correlation.
abstract: 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 (f(1)), similarity factor (f(2)) and level A IVIVC were evaluated showing that drug A is bioequivalent to drug B.
authors.affiliation: Department of Pharmacy, Faculty of Pharmacy and Alternative Medicines,The Islamia University of Bahawalpur, Bahawalpur 63100, Pakistan.
authors.forename: Sonia
authors.initials: S
authors.lastname: Khiljee
authors.forename: Mahmood
authors.initials: M
authors.lastname: Ahmad
authors.forename: Ghulam
authors.initials: G
authors.lastname: Murtaza
authors.forename: Asadullah
authors.initials: A
authors.lastname: Madni
authors.forename: Naveed
authors.initials: N
authors.lastname: Akhtar
authors.forename: Muhammad
authors.initials: M
authors.lastname: Akhtar
mesh_terms: D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D009643:Norfloxacin / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D013607:Tablets; D009643:Norfloxacin