Innovare Academic Sciences
International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491
Vol 7, Issue 5, 2015
Original Article
SIMULTANEOUS DETERMINATION OF NAPROXEN SODIUM AND ACETAMINOPHEN IN FIXEDDOSE COMBINATIONS FORMULATIONS BY FIRST-ORDER DERIVATIVE SPECTROSCOPY: APPLICATION TO DISSOLUTION STUDIES JOSÉ RAÚL MEDINA*, CARLOS ALFONSO LÓPEZ-TABLEROS, GERARDO HERNÁNDEZ-ALTAMIRANO, GEORGINA ALARCÓN-ÁNGELES, MARCELA HURTADO, ADRIANA MIRIAM DOMÍNGUEZ-RAMÍREZ Departamento de Sistemas Biológicos, Universidad Autónoma Metropolitana-Xochimilco, Mexico DF, Mexico. Email:
[email protected] Received: 27 Feb 2015 Revised and Accepted: 22 Mar 2015 ABSTRACT Objective: To validate and apply a new and easy zero-crossing derivative method for the simultaneous determination of naproxen sodium and acetaminophen in fixed-dose combinations formulations.
Methods: Measurement was achieved using the first-derivative (1D) signals at 243.42 nm for naproxen sodium and at 297.10 nm for acetaminophen. The method was validated according to International Conference on Harmonization (ICH) guidelines and was used to obtain the dissolution profiles (USP Apparatus 2, 75 rpm and 900 ml of 0.1 M phosphate buffer pH 7.4) of five generic products and the reference product Febrax® (275/300 mg of naproxen sodium and acetaminophen, respectively). Dissolution data: percent of drug dissolved at 60 min, mean dissolution time (MDT) and dissolution efficiency (DE) were compared by a univariate one-way analysis of variance (ANOVA) followed by Dunnett’s multiple comparisons test. Differences were considered significant if *P0.99, *P
