Physical and chemical stability of palonosetron HCl with cisplatin, carboplatin, and oxaliplatin during simulated Y-site administration

Abstract

The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron HCl 50 mcg/mL with cisplatin 0.5 mg/mL, carboplatin 5 mg/mL, and with oxaliplatin 0.5 mg/mL in infusion solutions during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron HCl with 7.5 mL of the cisplatin, carboplatin, and oxaliplatin dilutions. Physical stability was assessed using a multistep evaluation procedure that included both 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. Evaluations were performed initially upon mixing and 1 and 4 hours after mixing. The samples were clear and colourless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity remained unchanged and particulate content was low and exhibited little change. HPLC analysis found palonosetron HCl, cisplatin, carboplatin, and oxaliplatin remained stable throughout the 4-hour test with no drug loss. Palonosetron HCl is physically compatible and chemically stable with cisplatin, carboplatin, and oxaliplatin during Y-site administration.