Stability of dobutamine hydrochloride in selected large-volume parenterals

Stability of dobutamine hydrochloride when mixed with large-volume parenteral solutions was assessed. Dobutamine hydrochloride was added to large-volume solutions of 5% dextrose injection, 0.9% sodium chloride injection, lactated Ringer's injection, and 5% dextrose and 0.45% sodium chloride injection, in both glass and polyvinyl chloride containers; the initial concentration was 1 mg/ml. After 0.25, 1, 3, 8, 24, and 48 hours, the concentration of dobutamine hydrochloride was determined by high-pressure liquid chromatography assay, and each solution was visually examined for evidence of haze, precipitation, color change, or evolution of gas. Concentration of dobutamine hydrochloride in the samples did not exhibit any appreciable change over the 48-hour period, and no HPLC peaks indicating degradation products were noted. Color changes were observed in some of the solutions, but no other visual changes occurred. There were no apparent differences in stability between the admixtures packaged in glass and those in polyvinyl chloride bags. At the concentration studied, dobutamine hydrochloride is stable in the admixtures tested for a minimum of 48 hours.