Solubility of dronedarone hydrochloride in six pure solvents at the range of 298.15 to 323.15 K

Abstract

The aim of this study was to measure the mole fraction solubility of dronedarone hydrochloride in six pure solvents across a temperature range of 298.15–323.15K. The experimental solubility of dronedarone hydrochloride correlated with the Apelblat equation. The maximum mole fraction solubility of dronedarone hydrochloride was observed to be 0.119 in methanol at 323.15K followed by ethanol (3.62×10−2 at 323.15K), 1-propanol (1.59×10−2 at 323.15K), 1-butanol (8.05×10−3 at 323.15K), 2-propanol (2.93×10−3 at 323.15K), and water (6.11×10−5 at 323.15K). Based on these results, dronedarone hydrochloride can be considered freely soluble in methanol, soluble in ethanol, and slightly soluble in 1-propanol, 2-propanol, 1-butanol, and water. These data could be important for the recrystallization and formulation development of dronedarone hydrochloride.