3PC-007 Determination of the physicochemical stability of amiodarone hydrochloride in syringes for intensive care unit

BackgroundThe intensive care unit (ICU) use drug solutions with higher concentration to avoid fluid overload.PurposeTo determine the physicochemical stability of a concentrated solution of amiodarone in a polypropylene syringe during 28 days at 5°C±3°C with protection from light.Material and methodsFive syringes of 50 ml, containing 25 mg/ml of amiodarone in 0.9% NaCl were prepared and stored at 5°C±3°C with protection from light during 28 days. Immediately after preparation and periodically during the storage, amiodarone concentrations were measured by an ultra performance liquid chromatography (UPLC). Spectrophotometric absorbance at different wavelengths, pH measurement, and visual and microscopic observations were also performed.ResultsAll solutions were physico-chemically stable during the whole period storage at 5°C±3°C: no colour change, turbidity, precipitation or opacity, no significant pH variations or optic densities were observed in the solutions. Any crystals were seen by microscopic analysis. Solutions are considered chemically stable as the lower limit of the 95% unilateral confidence interval on the mean remained above 90% in the initial concentration for at least 28 days.ConclusionSolutions of amiodarone 25 mg/ml in syringes of 0.9% NaCl are physically and chemically stable for at least 28 days when stored in syringes at 5°C±3°C with protection from light and may be prepared in advance by a Centralised IntraVenous Admixture Service (CIVA).Reference and/or Acknowledgements1. Simar J, Delcave C, Godet M, Decoster C, Gillet P, Bihin B, Jamart J, Galanti LM, Hecq JD. Stabilité physique du chlorhydrate d’amiodarone dans des seringues de glucose 5% pour perfusion. Journal de Pharmacie de Belgique2016;98(1):24–25.No conflict of interest