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Abstract:  The purpose of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 0.25 mg admixed with dexamethasone (as sodium phosphate) 10 mg or 20 mg in 5% dextrose injection or 0.9% sodium chloride injection in polyvinylchloride minibags, and also admixed with dexamethasone (as sodium phosphate) 3.3 mg in 5% dextrose injection or 0.9% sodium chloride injection in polypropylene syringes, at 4°C stored in the dark for 14 days, and at 23°C exposed to normal laboratory fluorescent light over 48 hours.

Test samples of palonosetron hydrochloride 5 µg/mL with dexamethasone (as sodium phosphate) 0.2 mg/mL and also 0.4 mg/mL were prepared in polyvinylchloride minibags of each infusion solution. Additionally, palonosetron hydrochloride 25 µg/mL with dexamethasone (as sodium phosphate) 0.33 mg/mL in each infusion solution were prepared as 10 mL of test solution in 20-mL polypropylene syringes. Evaluations for physical and chemical stability were performed on samples taken initially and after 1, 3, 7 and 14 days of storage at 4°C and after 1, 4, 24 and 48 hours at 23°C. Physical stability was assessed using visual observation in normal room light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the drug was evaluated by using a stabilityindicating high-performance liquid chromatographic analytical technique.

All samples were physically compatible throughout the study. The solutions remained clear and showed little or no change in particulate burden and haze level. Additionally, little or no loss of palonosetron hydrochloride and dexamethasone occurred in any of the samples at either temperature throughout the entire study period.

Admixtures of palonosetron hydrochloride with dexamethasone sodium phosphate in 5% dextrose injection or in 0.9% sodium chloride injection packaged in polyvinylchloride minibags or in polypropylene syringes were physically compatible and chemically stable for at least 48 hours at room temperature and for 14 days under refrigeration.

Related Keywords: Lawrence A. Trissel, BS, RPh, FASHP, Yanping Zhang, BS, HPLC, concentration, Polyvinylchloride (PVC), dextrose, sodium chloride

Related Categories: INFUSION, PEER-REVIEWED, STABILITIES, COMPATIBILITIES

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