Abstract
Fluconazole is a novel triazole antifungistatic drug, which can be administered both orally and intravenously and is currently used for the treatment of systemic and superficial fungal infections. In this study, the solubility of fluconazole in water at elevated temperature and pressure was investigated at temperatures in the range of 298 to 473 K under autogenous- 5.0 MPa pressure. The results showed that the solubility of fluconazole was increased 146-fold at the highest experimental temperature of 473 K. Based on the experimental data, a mathematical model was developed to predict the solubility of fluconazole in subcritical water. The model was validated successfully and the theoretical solubility values matched well with the experimental data. Furthermore, a modified Apelblat equation provided a good fit to the experimental values except at low temperature. The molar enthalpy and the molar entropy of dissolution of fluconazole in subcritical water at temperatures ranging from 298 to 473 K were calculated. The good solubility of fluconazole in subcritical water allowed us to perform high temperature liquid chromatography (HTLC) for the determination of this agent. Moreover, thermogravimetric (TG) and differential scanning calorimetry (DSC) analysis confirmed that fluconazole had excellent thermal stability under subcritical conditions.
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