Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats
- *Corresponding Author:
- Aurigena Antunes deAraújo
Departamento de Biofísica e Farmacologia -
Centro de Biociências Av. Senador Salgado Filho
S/N - Lagoa Nova, 59078-900 – Natal - RN, Brazil
Tel: +55 84 32153419,
Fax: +55 84 32153402,
E-mail: [email protected]
Received Date: March 30, 2010; Accepted Date: April 23, 2010; Published Date: April 23, 2010
Citation: Silva Solon LG, Coelho Guerra GB, Araújo AA, Barichello JM, Pérez-Urizar J, et al. (2010) Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats. J Bioanal Biomed 2:048-054. doi:10.4172/1948-593X.1000021
Copyright: © 2010 Silva Solon LG, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.