Table of Contents
Chromatography Research International
Volume 2012, Article ID 610427, 8 pages
Research Article

Development and Validation of Dissolution Test for Fluconazole Capsules by HPLC and Derivative UV Spectrophotometry

1School of Pharmaceutical Sciences, Universidade Estadual Paulista, Rodovia Araraquara-Jaú km 1, 14801-902 Araraquara, SP, Brazil
2Department of Pharmaceutical Products, Federal University of Minas Gerais, Avenida Antônio Carlos 6627, 31270-901 Belo Horizonte, MG, Brazil

Received 7 December 2011; Revised 26 January 2012; Accepted 27 January 2012

Academic Editor: Bengi Uslu

Copyright © 2012 Josilene Chaves Ruela Corrêa 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.


The purpose of this study is to develop and validate a dissolution test for fluconazole, an antifungal used for the treatment of superficial, cutaneous, and cutaneomucous infections caused by Candida species, in capsules dosage form. Techniques by HPLC and UV first derivative spectrophotometry (UV-FDS) were selected for quantitative evaluation. In the development of release profile, several conditions were evaluated. Dissolution test parameters were considered appropriate when a most discriminative release profile for fluconazole capsules was yielded. Dissolution test conditions for fluconazole capsules were 900 mL of HCl 0.1 M, 37 ± 0.5 °C using baskets with 50 rpm for 30 min of test. The developed HPLC and UV-FDS methods for the antifungal evaluation were selective and met requirements for an appropriate and validated method, according to ICH and USP requirements. Both methods can be useful in the registration process of new drugs or their renewal. For routine analysis application cost, simplicity, equipment, solvents, speed, and application to large or small workloads should be observed.