Abstract
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.
Highlights
The dissolution can be defined in a narrow sense as the process by which a solid substance is incorporated into the solvent to form a solution
The dissolution test is an important tool in quality control of drugs and it becomes more important for drugs with relatively low water solubility, including broad spectrum antifungal fluconazole
A discriminative dissolution test for fluconazole capsules determination was presented in this study
Summary
The dissolution can be defined in a narrow sense as the process by which a solid substance is incorporated into the solvent to form a solution. In a broad sense, it is more than a simple measurement of solubility rate and can be better described as physical test to predict the drug release from a dosage form, for a given area for some precise time. This process is controlled by the affinity between the solvent and the solid substance and the way by which the pharmaceutical system releases the drug [1, 2]. Well-defined drug features, together with the dissolution studies, can be an important tool to justify the use of in vitro methods instead of in vivo methods when they are requested. The aim of this dissolution study is to contribute to define fluconazole dissolution conditions, what can be the focus for further studies
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