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Title: Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats
Authors: Araujo, Aurigena Antunes de
Solon, Lílian Grace da Silva
Guerra, Gerlane Bernardo Coelho
Barichello, José Mário
Pérez-Urizar, José
Soares, Luiz Alberto Lira
Keywords: Bioavailability studies;Validation;HPLC;Pharmacokinetics;Compounded naproxen sodium suspension
Issue Date: 23-Apr-2010
Publisher: J Bioanal Biomed
Citation: ARAUJO, Aurigena Antunes de; et al. Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats. Journal of Bioanalysis & Biomedicine, v. 2, p. 48-54, 2010. Disponível em: <> Acesso em: 13 mar. 2018.
Portuguese Abstract: The purpose of this study was to determine naproxen concentrations in rat plasma samples by HPLC and to compare the bioavailability of a generic and two compounded naproxen sodium suspensions (test 1 and test 2). Analysis was run at a fl ow rate of 1.2 mL.min -1 with a mobile phase of acetonitrile: NaH 2 PO 4 0.01 M pH 4.00 (50:50, v/v) at 280 nm, using a C 18 column (150 mm x 4.6 mm, 5 μ m). The calibration curve was linear (R 2 = 0.9987) over the range of 0.25 - 200 μ g.mL -1 . The precision for inter and intra-day analysis ranged from 2.46% to 12.39%. C max , T max and AUC t were 191.25 ± 11.17 μ g.mL -1 , 1.00 ± 0.106 h and 2438.16 ± 291.34 μ g.h.mL -1 for the reference drug, 188.22 ± 24.78 μ g.mL -1 , 1.06 ± 0.092 h and 1755.02 ± 228.90 μ g.h.mL -1 for test 1, and 160.50 ± 10.58 μ g.mL -1 , 0.66 ± 0.102 h and 1955.28 ± 142.80 μ g.h.mL -1 for test 2. No signi fi cant differences were found based on analysis of variance, with mean values and 90% CI of test2/reference ratio (C max 83.92% and AUC t 80.19%). For test1/reference ratio, the result was C max 98.41% and AUC t 71.98%. Based on these results, it can be concluded that the validated method was successfully applied to this study; the test 1 formulation failed to demonstrate a bioequivalence to the reference drug; however, the test 2 and reference naproxen sodium suspension were bioequivalent in terms of the rate and extent of absorption under these conditions.
ISSN: 1948-593X
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