| Research Article |
Open Access |
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| Comparative Bioavailability of a Generic and Two Compounded Naproxen
Sodium Suspensions Administered to Rats |
| Lílian Grace da Silva Solon1, Gerlane Bernardo Coelho Guerra2, Aurigena Antunes de Araújo2*, José Mário Barichello3, José Pérez-Urizar4 and Luiz Alberto Lira Soares5 |
| 1Department of Pharmacy,Universidade Federal do Rio Grande do Norte. Natal, Brazil
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| 2Department of Biophysics and Pharmacology, Universidade Federal do Rio Grande do Norte. Natal, Brazil |
| 3Department of Medicines, Universidade Federal da Bahia, Salvador, Brazil |
| 4Pharmacology and Physiology Laboratory, Universidad Autónoma de San Luis Potosí, SLP, Mexico |
| 5Department of Pharmacy, Universidade Federal de Pernambuco, Recife, Brazil |
| *Corresponding author: |
Aurigena Antunes de Araújo,
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: aurigena@ufrnet.br |
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| 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. |
| |
| 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 flow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile: NaH2PO4 0.01 M pH 4.00 (50:50, v/v) at 280 nm, using a C18 column (150 mm x 4.6 mm, 5 μm). The calibration curve was linear (R2 = 0.9987) over the range of 0.25 - 200 μg.mL-1. The precision for inter and intra-day analysis ranged from 2.46% to 12.39%. Cmax, Tmax and AUCt were 191.25 � 11.17 μg.mL-1, 1.00 � 0.106 h and 2438.16 � 291.34 μg.h.mL-1 for the reference drug, 188.22 � 24.78 μg.mL-1, 1.06 � 0.092 h and 1755.02 � 228.90 μg.h.mL-1 for test 1, and 160.50 � 10.58 μg.mL-1, 0.66 � 0.102 h and 1955.28 � 142.80 μg.h.mL-1 for test 2. No signifi cant differences were found based on analysis of variance, with mean values and 90% CI of test2/reference ratio (Cmax 83.92% and AUCt 80.19%). For test1/reference ratio, the result was Cmax 98.41% and AUCt 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.� |
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