Solubility of 3-ethyl-5-methyl-(4 RS)-2-((2-aminoethoxy)methyl)-4-(2- chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate monobenzenesulfonate (amlodipine besylate) in ethanol + water and propane-1,2-diol + water mixtures at various temperatures

Abstract

Solubilities of amlodipine besylate (AMB) in binary mixtures of ethanol (EtOH) + water and propane-1,2-diol or propylene glycol (PG) + water at (293.2, 298.2, 303.2, 308.2, and 313.2) K at atmospheric pressure are reported. In the EtOH + water system, the maximum mole fraction solubility of AMB was observed at 313.2 K and an EtOH mass fraction of 0.65. The corresponding value for PG + water mixtures was obtained in a PG mass fraction of 0.80 at 313.2 K. A combination of the Jouyban-Acree model and van't Hoff equation was used to predict the solubility of AMB in the mixed solvents at different temperatures. A mean relative deviation of 13.5 % was obtained for the correlated data. The generated solubility data and the derived computations could be used in the pharmaceutical industry where such information is required to speed up the process design. © 2012 American Chemical Society.