The stability of fludarabine phosphate in concentrate and diluted with sodium chloride 0.9%

Background: To determine the stability of fludarabine phosphate in concentrate in glass containers and diluted with sodium chloride 0.9% in polyethylene (PE) bags.

Material and methods : Solutions of fludarabine phosphate 25 mg/ml (concentrate) in glass containers (n = 6) were opened and stored at refrigerator temperature (2-8°C) and at room temperature (15-25°C). Another six solutions of fludarabine phosphate were diluted in NaCl 0.9% and stored in PE bags in the same conditions (2-8°C and 15-25°C). Samples of each solution from the 12 containers were analysed for fludarabine phosphate concentration initially and after 0.5, 1, 1.5, 2, 2.5, 3, 13 and 15 days of storage. Samples were assayed by a high performance liquid chromatographic (HPLC) method with ultraviolet detection ( = 265 nm) to determine the fludarabine phosphate concentration at each time of sampling.

Results : The concentration of fludarabine phosphate at each sampling time in the analysed solutions remained within 93.3-102.0% of the initial concentration, regardless of the storage temperature and container.

Conclusions : Fludarabine phosphate, both undiluted in glass containers and diluted with NaCl 0.9% in PE bags, remains stable (< 10% degradation) for at least 15 days at room and refrigerator temperature.