Stability of phenoxybenzamine hydrochloride in various vehicles

Abstract

The stability of phenoxybenzamine hydrochloride in various oral liquids was studied. Phenoxybenzamine hydrochloride powder or capsules were combined with various vehicles to prepare 10-mL formulations with a drug concentration of 2 mg/mL and a 20-mL stock solution containing 10 mg/mL. All formulations were prepared in triplicate and stored at 4 °C. A 1.0-mL sample of each of the g mg/mL formulations was withdrawn on days 0, 1, 2, 3, and 4, and samples of selected formulations were taken on days 7 and 10. Samples of the stock solution were withdrawn on days 0, 2, 4, 7, 10, 14, and 30. All samples were analyzed by highperformance liquid chromatography. Phenoxybenzamine hydrochloride 2 mg/mL was stable for a longer time in 1% propylene glycol. 0.15% citric acid, and water than in a similar vehicle in which syrup was used in place of water. The concentrations of the drug in both the 10-mg/mL stock solution and stock solutions diluted to 2 mg/mL were >90% of the initial drug concentration for 30 days. Phenoxybenzamine hydrochloride 2 mg/mL in 1% propylene glycol and 0.15% citric acid in distilled water was stable for 7 days at 4 °C. A stock solution of phenoxybenzamine hydrochloride 10 mg/mL in propylene glycol was stable for 30 days at 4 °C and, after dilution with 66.7% sucrose in distilled water to a concentration of 2 mg/mL, for up to one hour at 4 °C.