Physical and Chemical Stability of Palonosetron Hydrochloride with Dacarbazine and with Methylprednisolone Sodium Succinate During Simulated Y-Site Administration

Trissel, Lawrence A; Xu, Quanyun A; Zhang, Yanping

Abstract

Physical and Chemical Stability of Palonosetron Hydrochloride with Dacarbazine and with Methylprednisolone Sodium Succinate During Simulated Y-Site Administration

Author(s): Trissel Lawrence A, Xu Quanyun A, Zhang Yanping

Issue: May/Jun 2006 - Hormone Replacement Therapy

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Page(s): 234-236

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Abstract

The objective of this study was to evaluate the physical and chemical stability of mixtures of undiluted palonosetron hydrochloride 50 µg/mL with dacarbazine 4 mg/mL and with methylprednisolone sodium succinate 5 mg/mL in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of dacarbazine solution and, separately, methylprednisolone sodium succinate solution. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatographic analytical techniques that determined drug concentrations. Evaluations were performed immediately after mixing and 1 and 4 hours after mixing. The palonosetron hydrochloride-dacarbazine samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a

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