Abstract

The use of accelerated temperature stability studies using the Arrhenius
relationship is routine for estimating the stability of a drug at room temperature.
Therefore, the acceleration method is used to determine the expiration date of
dexamethasone aqueous formulation manufactured in Iran. A high-performance
liquid chromatography (HPLC) method utilizing ultraviolet (UV) detection for
dexamethasone disodium phosphate and ophthalmic solution is described.
Using the kinetic information generated from the high-temperature studies, at
60,70, 80 and 90°C, an Arrhenius plot for dexamethasone disodium phosphate
degradation was constructed and the shelf-life of the drug was estimated