Stability of the ready-to-use solutions of eribulin for intravenous infusion

• Published in: Annales pharmaceutiques françaises Vol. 70; no. 5; p. 249
• Main Authors: Poujol, S, Dell'ova, M, Bekhtari, K, Bressolle, F, Pinguet, F
• Format: Journal Article
• Language: English
• Published: France 01.09.2012
• Subjects: Calibration; Chromatography, High Pressure Liquid; Drug Stability; Furans - administration & dosage; Furans - chemistry; Indicators and Reagents; Infusions, Intravenous; Ketones - administration & dosage; Ketones - chemistry; Pharmaceutical Solutions; Quality Control; Reproducibility of Results; Spectrophotometry, Ultraviolet
• ISSN: 0003-4509
• DOI: 10.1016/j.pharma.2012.06.004

A simple HPLC-UV method was developed to determine the stability of ready-to-use eribulin solutions under different storage conditions. The developed method was validated with respect to linearity, accuracy, precision and ruggedness. The following admixtures were prepared: 3-mL polypropylene syringes at concentration of 440 μg/mL and multilayer laminate polyolefin containers containing 0.9% sodium chloride (50 mL) at concentrations of 15.4 and 43.3 μg/mL. The open-vial stability of eribulin was also evaluated. The following storage conditions were tested: 4 °C in the refrigerator; 20 °C under room light exposure; and 20 °C with light-protection. The drug was also subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The retention time of eribulin was 4.9 min. Admixtures of eribulin solutions in vials, syringes or polyolefin bags at clinically relevant concentrations were physically compatible and chemically stable for at least 14 days at 4 °C in the refrigerator and at 20 °C with or without any protection against light. Degradation was only found to occur under oxidation conditions.