Compatibility and stability of palonosetron hydrochloride and propofol during simulated y-site administration

Palonosetron hydrochloride is a longer-acting, selective 5-HT3 receptor antagonist that has been approved for prevention of chemotherapy-induced nausea and vomiting and is being evaluated for prevention of postoperative nause and vomiting. The objective of this study was to evaluate the physical and chemical stablity of palonosetron hydrochloride 50 mcg/mL when mixed with undiluted propofol 1% during simulated Y-site administation. Duplicate samples of this mixture were tested. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by visual inspection. Chemical stability was assessed by high-performance liquid chromatographic analysis. All of the admixtures were opaque white when viewed in normal fluorescent room light and when viewed with a Tyndall beam. After centrifugation, no evidence of precipitation was found. The drug concentrations were essentially unchanged in all of the samples throughout the study. Palonosetron hydrochloride is physically and chemically stable when mixed with propofol as undiluted injections during simulated Y-site administration over 4 hours at ambient room temperature.