Stabilité à long terme de la dexaméthasone en association avec de l'alizapride ou de l'ondansetron dans une solution de chlorure de sodium 0,9 % dans des poches de perfusion de polyoléfine conservées à 5 ± 3 °C

Introduction The aim of the study was to investigate the long-term stability of dexamethasone 10 mg associated with alizapride 100 mg or ondansetron 8 mg in 100 mL of 0.9% sodium chloride solution stored at 5 ± 3 °C. Method Solutions of 0.9% sodium chloride 100 mL in polyolefin bags (n = 5) containing approximately dexamethasone (DEX) 10 mg associated with alizapride (ALI) 100 mg or ondansetron (OND) 8 mg were prepared under aseptic conditions and stored about 30 days at 5 ± 3 °C. ALI, DEX and OND concentrations were measured by high-performance liquid chromatography (HPLC). Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCL 5M and NaOH 5M before and after heating at 100 °C was also performed. Solutions were considered stable if the 95% one-sided lower confidence limit of the concentration remains superior to 90% of the initial concentration or 95% of the initial concentration when any signs of physical instability exist as recently recommend. Results The calibration was linear over the following range from 20 to 1.25 mg/100 mL for DEX, from 200 to 12.5 mg/100 mL for ALI and from 20 to 1.25 mg/100 mL for OND with a calculated correlation coefficient (r²) of 0.998, 0.999 and 0.999, respectively. The inter- and intra-assay precision was below 10% for both mixtures. All formulations were physically stable during the storage. The lower confidence limit of the concentration for these solutions remains superior to 90% of the initial concentration at this date as recommended by the Food and Drug Administration (FDA) until 30 days. Conclusion The HPLC method is specific and reproducible and can easily be adopted for monitoring the quality control in the production of DEX-ALI and DEX-OND bags. Solutions of DEX-ALI and DEX-OND were physically and chemically stable for 30 days in polyolefin bags stored at 5 ± 3 °C and could therefore be prepared in advance.