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Evaluation of the Physicochemical Stability of Amiodarone Hydrochloride in Syringes for the Intensive Care Unit

Author(s):  Lardinois Benjamin, Dimitriou Alexandre, Delcave Charlotte, Jamart Jacques, Bihin Benoît, Soumoy Laura, Hecq Jean-Daniel, Galanti Laurence M

Issue:  Mar/Apr 2019 - Volume 23, Number 2
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Abstract:  In some emergency clinical situations, the injection of a more concentrated drug solution in the intensive care units is common. The purpose of this study was to evaluate the physicochemical stability of concentrated solutions of amiodarone hydrochloride in polypropylene syringes during 28 days of storage at 5°C ± 3°C, with protection from light. Five syringes of 50 mL, containing 25 mg/mL of amiodarone in dextrose 5%, 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 hydrochloride concentrations were measured by ultra-performance liquid chromatography. Spectrophotometric absorbance at different wavelengths, pH measurement, and microscopic observations were also performed. All solutions were physicochemically stable during the study period when stored at 5°C ± 3°C. No color change, turbidity, precipitation, opacity, significant pH variations, or optic densities were observed in the solutions. No crystals were seen by microscopic analysis. The concentration of amiodarone did not decrease during the 28 days of storage. Solutions of amiodarone 25 mg/mL in syringes of dextrose 5% 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 advanced by a centralized intravenous additive service.

Related Keywords: Benjamin Lardinois, MD, Alexandre Dimitriou, MLT, Charlotte Delcave, PharmD, Jacques Jamart, MD, MSc, Benoît Bihin, MSc, Laura Soumoy, PharmD, Jean-Daniel Hecq, PharmD, PhD, Laurence M. Galanti, MD, PhD, amiodarone hydrochloride, intensive care unit, physical stability, concentration variation, chemical stability, storage conditions

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, CARDIOLOGY

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