Physical and Chemical Stability of Palonosetron Hydrochloride with Fluorouracil and with Gemcitabine Hydrochloride during Simulated Y-site Administration

Trissel, Lawrence A; Zhang, Yanping

Abstract

Physical and Chemical Stability of Palonosetron Hydrochloride with Fluorouracil and with Gemcitabine Hydrochloride during Simulated Y-site Administration

Author(s): Trissel Lawrence A, Zhang Yanping

Issue: Jul/Aug 2005 - Human Hormone Replacement Therapy

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Page(s): 320-322

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Abstract

The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron 50 µg/mL as the hydrochloride with fluorouracil 16 mg/mL, and with gemcitabine 10 mg/mL as the hydrochloride, 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 the fluorouracil and gemcitabine hydrochloride admixtures. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurements 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 initially upon mixing and 1 and 4 hours after mixing. The samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity remained unchanged; particulate cont

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