Determination of amiodarone hydrochloride solubility in pure and ethanol-modified subcritical water: Experimental data and modeling

Abstract

In the present research, the solubility of amiodarone hydrochloride (AMD), an antiarrhythmic drug, in pure and ethanol-modified subcritical water (SW) was obtained for the first time. The measurements were carried out at different temperatures between 298.15 and 393.15 K and 0–10% (w/w) of ethanol as a cosolvent under the constant pressure of 50 bar by employing a static method. It was found that the solubility of AMD was between 0.14 × 10-4 to 2.85 × 10-4 mol fractions while its solubility by cosolvent was between 0.31 × 10-4 to 9.82 × 10-4 mol fractions under the conditions mentioned above. The results revealed the significant and dramatic influence of temperature on AMD solubility. The experimental solubility data have been modeled with two popular semi-empirical temperature-based models, including the linear and modified Apelblat models. The values of adjusted correlation coefficient (Radj), correlation coefficient (Rsqure), and root-mean-square deviation (RMSD) between empirical and calculated solubilities were calculated and utilized as the index of accuracy and validity of the model. The obtained outcomes revealed the superior performance of the modified Apelblat model among the tested models. Finally, thermodynamic quantities of dissolution have been calculated.