{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "University of Franche-Comté, Besançon, Bourgogne-Franche-Comté, France",
        "Pôle Pharmaceutique, CHRU de Besançon, Besançon, Bourgogne-Franche-Comté, France"
      ],
      "name": "Yves Guillaume"
    },
    {
      "affiliations": [
        "Franche-Comte University Faculty of Medical and Pharmaceutical Sciences, Besancon, France"
      ],
      "name": "Claire André"
    },
    {
      "affiliations": [
        "Franche-Comte University Faculty of Medical and Pharmaceutical Sciences, Besancon, France"
      ],
      "name": "Lydie Lethier"
    }
  ],
  "title": "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",
  "uid": "8b8e733c-9611-5503-a3e7-589168c9763a"
}