Drug Discov Ther. 2022;16(1):1-7. (DOI: 10.5582/ddt.2022.01011)

Stability of extemporaneously compounded 5-fluorouracil utilizing high performance liquid chromatography

Komm C, Rochani A, Fox T, Kaushal G


The goal of the current study is to determine stability of compounded 5-fluorouracil (5-FU) in Intravia™ bags and CADD™ cassettes stored up to 15 days under refrigeration (2-8°C) and room temperature (25°C with 60% relative humidity), with four different concentrations (20 mg/mL, 30 mg/mL, 40 mg/mL, and 50 mg/mL) and two diluents (0.9% sodium chloride and 5% dextrose). A stability-indicating high-performance liquid chromatography (HPLC) method was developed to analyze the 5-FU concentrations. The stability of compounded 5-FU infusions was investigated using this method. Two samples from each storage condition were assessed for stability on days 0, 4, 7, 10, and 15 as per United States Pharmacopeia (USP) guidelines. The assay of 5-FU was done utilizing a calibrated stability-indicating HPLC method. The stability-indicating HPLC assay showed 5-FU completely degraded within 1 hour in basic conditions. No cloudiness or color change was observed during the stability study. Precipitation was observed in the CADD™ cassettes at day 15 in both storage conditions and at day 10 in a single room-temperature CADD™ cassette for 40 mg/mL in 5% dextrose (D5W). HPLC assay revealed the infusions in CADD™ cassettes retained greater than 90% of the initial concentrations of 5-FU for 15 days stored at room temperature (25°C and 60% relative humidity) and for 10 days at refrigeration (2-8°C). Intravia™ bags retained stability through 15 days for all the compounded 5-FU concentrations and both the storage conditions. 5-FU infusions in both CADD™ cassettes and Intravia™ bags were stable for extendable periods in multiple concentrations compared to recommended guidelines for hospital use.

KEYWORDS: 5-Fluorouracil, compounding, stability, high performance liquid chromatography

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