title: Validated HPLC-UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol.
abstract: Estimating the influence of interfering compounds present in the biological matrix on the determination of an analyte is one of the most important tasks during bioanalytical method development and validation. Interferences from endogenous components and, if necessary, from major metabolites as well as possible co-administered medications should be evaluated during a selectivity test. This paper describes a simple, rapid and cost-effective HPLC-UV method for the determination of naproxen in human plasma in the presence of two other analgesics, ibuprofen and paracetamol. Sample preparation is based on a simple liquid-liquid extraction procedure with a short, 5 s mixing time. Fenoprofen, which is characterized by a similar structure and properties to naproxen, was first used as the internal standard. The calibration curve is linear in the concentration range of 0.5-80.0 µg/mL, which is suitable for pharmacokinetic studies following a single 220 mg oral dose of naproxen sodium. The method was fully validated according to international guidelines and was successfully applied in a bioequivalence study in humans. Copyright © 2015 John Wiley & Sons, Ltd.
authors.affiliation: Pharmaceutical Research Institute, Pharmacology Department, 8 Rydygiera Street, 01-793, Warsaw, Poland.
authors.forename: Monika
authors.initials: M
authors.lastname: Filist
authors.affiliation: Medical University of Warsaw, Department of Drug Chemistry, 1 Banacha Street, 02-097, Warsaw, Poland.
authors.forename: Iwona
authors.initials: I
authors.lastname: Szlaska
authors.affiliation: Pharmaceutical Research Institute, Pharmacology Department, 8 Rydygiera Street, 01-793, Warsaw, Poland.
authors.forename: Michał
authors.initials: M
authors.lastname: Kaza
authors.affiliation: Medical University of Warsaw, Department of Drug Chemistry, 1 Banacha Street, 02-097, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pawiński
mesh_terms: D000082:Acetaminophen / Q000097:blood*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D007052:Ibuprofen / Q000097:blood*; D009288:Naproxen / Q000097:blood*; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D009288:Naproxen; D007052:Ibuprofen
keywords: HPLC; method selectivity; method validation; naproxen; pharmacokinetics