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ISRN Chromatography
Volume 2012 (2012), Article ID 582375, 9 pages
http://dx.doi.org/10.5402/2012/582375
Research Article

Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

1Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade de Medicamentos, Universidade Federal do Pampa (UNIPAMPA), BR 472 Km 585, Prédio Administrativo, 97500-970 Uruguaiana, RS, Brazil
2Laboratório 402, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Avenida Ipiranga 2752, 90610-000 Porto Alegre, RS, Brazil
3Programa de Pós-graduação em Bioquímica, Universidade Federal do Pampa (UNIPAMPA), BR 472 Km 585, Prédio Administrativo, 97500-970 Uruguaiana, RS, Brazil

Received 2 January 2012; Accepted 23 January 2012

Academic Editors: B. Carbonnier, C. Fente Sampayo, and A. Namera

Copyright © 2012 Fábio Barbosa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A stability-indicating liquid chromatographic (LC) method was studied for the determination of paliperidone in osmotic-controlled release oral delivery system (OROS) tablets. A tablet extraction procedure was developed by testing the efficiency of solvents (water, HCl, NaOH, acetonitrile, methanol) and techniques (ultrasonic bath, magnetic stirrer), and evaluating the release of the drug with respect to time. A forced degradation study was conducted to demonstrate the stability-indicating power of the method. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system with a mobile phase prepared from a mixture of phosphate buffer and acetonitrile. The use of an ultrasonic bath demonstrated paliperidone release from OROS tablets in a total time of 60 min. Verifying the efficiency of the chromatographic procedure, the theoretical plates ( 𝑁 = 1 2 6 3 4 . 2 1 ) and tailing factor ( t f = 1 . 3 1 ) were constant during repeated injections. The retention time of paliperidone was 4.8 min, and the method was validated within the concentration range of 10–50 μg mL−1 ( 𝑟 = 0 . 9 9 9 9 ). Adequate reproducibility (RSD% = 0.30–0.59), interday precision ( R S D % = 1 . 8 1 ), and accuracy were obtained. The proposed method was successfully applied to paliperidone determination in the presence of degradation products, and an efficient extraction procedure from the OROS tablets was developed.