Abstract
Measuring and evaluating of the solubility of amlodipine besylate (AMB), as a low water soluble antihypertensive drug, is fundamentally important in the pharmaceutical industry. In this work, the solubility of AMB in the binary solvent system of water and polyethylene glycol 400 (PEG 400) was determined by a shake-flask method at the temperatures from 293.2 to 313.2 K. According to the obtained results, the solubility of AMB increases nonlinearly with increasing the mass fraction of PEG 400. The maximum mole fraction solubility of AMB was observed at 313.2 K with a PEG 400 mass fraction of 0.9. The experimental solubility data points were correlated by Jouyban-Acree, Jouyban-Acree-van’t Hoff and CNIBS/R-K as linear models and NRTL, Wilson and UNIQUAC as nonlinear models. Of them CNIBS/R-K and NRTL models performed the best in correlation results. The dissolution and mixing thermodynamic properties such as enthalpy, Gibbs free energy, and entropy were also calculated based on Gibbs and van’t Hoff equations to investigate the solvation behavior of AMB in the aqueous PEG 400 mixtures. The density values of AMB saturated mixtures of the PEG 400 and water at different temperatures were also measured and correlated with the Jouyban-Acree model.
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