Physicochemical Characterization of Trazodone Hydrochloride Tetrahydrate.

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Abstract

Trazodone hydrochloride tetrahydrate was isolated and characterized by moisture absorption equilibrium, Karl Fischer method, powder X-ray diffractometry, infrared (IR) spectroscopy and elementary analysis. Trazodone hydrochloride (anhydrate) showed a supersaturation phenomenon in the dissolution process in water. In water and under high humidity condition (>93% relative humidity), trazodone hydrochloride was converted into the hydrate (trazodone hydrochloride : H2O=1 : 4). The hydrate dehydrated under less than 51% relative humidity at 25°C. The activation energy for dehydration reaction from the hydrate to the anhydrate determined by a non-isothermal method (Ozawa method) was 37.1 kcal/mol.

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