Abstract
The objective of this study was to evaluate the physical and chemical stability of ciprofloxacin 400 mg/100 mL and vancomycin as the hydrochloride 1 g/100 mL each admixed in 0.9% sodium chloride injection packaged in AutoDose Infusion System bags.
Triplicate test samples were prepared by admixing the necessary amount of each antibiotic with a portion of 0.9% sodium chloride injection and bringing the admixture of each drug to a final volume of 100 mL with additional 0.9% sodium chloride injection. The test solutions were packaged in ethylene vinyl acetate (EVA) plastic containers (AutoDose dags) designed for use in the AutoDose Infusion System. Samples were protected from light and evaluated at appropriate intervals for up to 7 days at 23°C and up to 30 days at 4°C.
Physical stability was assessed using a multistep evaluation procedure that included turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed using stability-indicating HPLC analytical techniques based on the determination of drug concentrations initially and at appropriate intervals over the study periods. The admixtures were clear and colorless when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change. HPLC analysis found that both ciprofloxacin and vancomycin hydrochloride remained stable for 30 days at 4°C and 7 days at 23°C.
Both ciprofloxacin and vancomycin hydrochloride exhibited physical and chemical stability consistent with previous studies on these drugs. The AutoDose Infusion System bags were not found to affect adversely the physical and chemical stability of these antibiotics.