title: Validated HPLC method for the pharmacokinetic study of oral extended-release cefpodoxime proxetil chitosan-alginate beads in rabbits.
abstract: The aim of this study is to develop a simple and applicable HPLC method for the detection of cefpodoxime acid (CFA) in rabbit plasma after oral administration of cefpodoxime proxetil (CFP) loaded chitosan-alginate (CH-ALG) beads formulation. CFP is a prodrug that is deesterified in vivo to its active metabolite CFA to exhibit antibiotic activity. Chromatographic separation of CFA and internal standard (IS) was achieved by a RP18(C18), Phenomenax®100, (250×4.6mm) with the mobile phase consisting of (0.02mol/l (20mM) ammonium acetate solution and acetonitrile (92:8, v/v, pH=4.6) at a flow rate of 1.0ml/min. The method was validated according to the requirements of US-FDA guidelines for bioanalytical method validation. The linear regression analysis for the calibration plots showed good linear relationship (R2=0.9905) in the working concentration range of 0.5-50μg/ml. The limits of detection and quantification (S/N=3) were 0.069 and 0.136μg/ml. Plasma CFA levels were successfully determined in rabbit with satisfactory precision and accuracy. The analyte was found to be stable after a number of stability studies. The proposed HPLC method was successfully applied to pharmacokinetic study in rabbits for CFP loaded CH-ALG beads and marketed immediate release (IR) tablets. All pharmacokinetic parameters were assessed.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Northern Border University, Rafha, Saudi Arabia. Electronic address: ali_jh82@yahoo.com.
authors.forename: Ali
authors.initials: A
authors.lastname: Mujtaba
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi 110062, India.
authors.forename: Kanchan
authors.initials: K
authors.lastname: Kohli
mesh_terms: D000284:Administration, Oral; D000464:Alginates / Q000737:chemistry*; D000818:Animals; D015296:Ceftizoxime / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000493:pharmacokinetics; D048271:Chitosan / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004337:Drug Carriers / Q000737:chemistry; D065546:Drug Liberation; D020723:Glucuronic Acid / Q000737:chemistry; D006603:Hexuronic Acids / Q000737:chemistry; D057230:Limit of Detection; D016014:Linear Models; D008863:Microspheres; D011817:Rabbits; D000097627:Cefpodoxime Proxetil
chemical_list: D000464:Alginates; D015296:Ceftizoxime; D048271:Chitosan; D004337:Drug Carriers; D020723:Glucuronic Acid; D006603:Hexuronic Acids; D000097627:Cefpodoxime Proxetil
keywords: Bioanalytical method; Cefpodoxime; HPLC; Pharmacokinetic; Rabbit plasma