STABILITY OF DOBUTAMINE HYDROCHLORIDE IN PERITONEAL-DIALYSIS SOLUTIONS

The stability of dobutamine hydrochloride in peritoneal dialysis solutions at 4, 26, and 37-degrees-C was determined. Dobutamine (as the hydrochloride salt) was added to dialysis solutions containing 1.5% or 4.25% dextrose to concentrations of 2.5, 5.0, and 7.5 mg/mL. Samples were stored at 4, 26, and 37-degrees-C to mimic refrigerator, room, and body temperature, respectively. At 0, 4, 8, and 24 hours, the samples were analyzed in triplicate by stability-indicating high-performance liquid chromatography to determine the percentage of drug remaining. More than 90% of the drug was retained under all storage conditions in 1.5% dextrose dialysate containing an initial dobutamine hydrochloride concentration of 5.0 or 7.5-mu-g/mL. The mean concentration in the samples containing an initial dobutamine hydrochloride concentration of 2.5-mu-g/mL and stored at room temperature remained greater than 90% of the initial concentration for the first four hours and then decreased to less than 90%. Dobutamine was stable in 4.25% dextrose dialysate regardless of the initial concentration or the storage condition. Dobutamine hydrochloride 5.0 and 7.5-mu-g/mL in 4.25% dextrose dialysis solution was stable under all the test conditions. Dobutamine hydrochloride 2.5-mu-g/mL was stable in 1.5% dextrose dialysate for only four hours at room temperature.