Physicochemical and Bioequivalence Studies on Some Brands of Levofloxacin Tablets Registered in Nigeria | Zendy

Chukwuemeka Azubuike | Zendy; Samson Oluyase | Zendy

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Physicochemical and Bioequivalence Studies on Some Brands of Levofloxacin Tablets Registered in Nigeria

Author(s) -

Chukwuemeka Azubuike,

Samson Oluyase

Publication year - 2014

Publication title -

british journal of pharmaceutical research

Language(s) - English

Resource type - Journals

ISSN - 2231-2919

DOI - 10.9734/bjpr/2014/12355

Subject(s) - bioequivalence , bioavailability , innovator , friability , cmax , pharmacokinetics , levofloxacin , mathematics , pharmacology , traditional medicine , medicine , chemistry , business , biochemistry , finance , first pass effect , entrepreneurship , antibiotics

Aims: This study was aimed at comparing the physicochemical and bioavailability profilesof some brands of Levofloxacin 500mg tablets that are registered in Nigeria by herregulatory authority and to examine the feasibility of interchangeability of the brands.Methodology: The physicochemical equivalence of ten brands of Levofloxacin 500 mgtablets (LEV-1 to LEV-10) were evaluated using both official and unofficial standardsincluding weight variation, hardness, friability test, chemical assay, disintegration,dissolution rate and drug content. Five of the brands were also evaluated forbioavailability profiles using a single dose randomized two period cross–over designsmeasuring the concentration of drugs in the urine. Urinary samples before dosing and atvarious appropriate time intervals up to 12 hours were analyzed by validated DoubleBeam U. V. Spectrophotometer method with 99.8% extraction recovery. Pharmacokineticparameters for bioequivalence evaluation C

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