Fully validated HPLC-UV detection method associated with colour variation control for evaluation of the stability of 5-fluorouracil chemotherapy polyolefin infusion bags at dose banding

OBJECTIVES: To develop a fully validated high-performance liquid chromatography (HPLC) stability-indicating assay for measuring the concentration and physical stability of 5-fluorouracil (5-FU) at standardised rounded doses in polyolefin (POF) infusion. METHODS: Diluted 5-FU infusion solutions were aseptically prepared by further dilution of a 5-FU stock solution with 0.9% sodium chloride in POF bags, at banded doses between 500 mg and 800 mg. The POF bags were stored under refrigeration (4°C) in the dark (long-term stability conditions) or at room temperature (25°C) in daylight for a short period of 24 hours (simulated in-use conditions). RESULTS: The long-term stability of 5-FU at selected standardised rounded doses (500-800 mg) in NaCl 0.9% in POF bags was confirmed for 3 months at 4°C in the dark. Additionally, during the simulated in-use study, no signs of chemical instability were observed. CONCLUSIONS: A stability-indicating HPLC method was developed to determine 5-FU concentrations in dose-banding conditions associated with colour variation investigations. This study supports a centralised production of 5-FU at standardised dose banding.