Stability of Amikacin Sulfate in AutoDose Infusion System Bags

The objective of this study was to evaluate the physical and chemical stability of amikacin 25mg/100mL and 500mg/100mL as the sulfate salt admixed in 0.9% sodium chloride injection and packaged in AutoDose Infusion System bags. Triplicate test samples of each concentration were prepared by admixing the necessary amounts of the amikacin sulfate with a portion of 0.9% sodium chloride injection. The admixtures were brought to a final volume of 100mL with additional 0.9% sodium shloride injection. The test solutions were packaged in AutoDose bags, which are ethylene vinyl acetate plastic containers designed for use in the AutoDose Infusion System. Samples were stored protected from light and evaluated at appropriate intervals for up to 7 days at 23 deg C and up to 30 days at 4 deg C. Physical stability was assessed by means of a multistep evaluation procedure that included both turbidimetric and particulate measurement, as well as visual inspection. Chemical stability was assessed by stability-indicating high-performance liquid chromatographic analytical techniques based on the determination of initial drug concentrations and drug concentrations at appropriate intervals over the study periods. The amikacin sulfate admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change. High-performance liquid chromatographic analysis indicated that the amikacin sulfate remained stable for 30 days at 4 deg C and for 7 days at 23 deg C. At both concentrations, amikacin sulfate exhibited physical and chemical stability consistent with previous studies of this drug. The AutoDose Infusion System bags did not adversely affect the physical and chemical stability of the amikacin sulfate.