Background The physical stability of injectable drugs must be proved to ensure patient safety.
Purpose To investigate the physical stability of amiodarone hydrochloride 600 mg in 12 mL of 5% glucose solution stored at room temperature
Material and methods 5 polypropylene syringes of 600 mg of amiodarone hydrochloridee were prepared under aseptic conditions and stored at room temperature for 48 h. Immediately after the preparation (hour 0) and after hours 1, 4, 8, 24 and 48 of storage, 2 mL of solution were withdrawn from each syringe and placed in glass tubes. Then, each solution was visually inspected in front of a black and white background and a centrifuged aliquot was examined microscopically. The pH of each solution was measured with a glass electrode pH-metre (Inolab level 1, WTW Weilhem, Germany with biotrode electrode, Hamilton, Bonaduz, Switzerland) and spectrophotometric measurements (Genesys 10 series, New-York, USA) were performed at three wavelenghts: 350, 410 and 550 nm.
Results There was no colour change, no turbidity or opacity, and no precipitation observed in the solutions during storage at room temperature for 48 h. No microaggregate was observed microscopically or revealed by a change in absorbance. There was no significant change in pH during storage.
Conclusion According to this study, amiodarone hydrochloride in 5% glucose polypropylene syringes is physically stable at room temperature for 48 h. These results allow us to consider a study of chemical stability by high performance liquid chromatography.
References and/or Acknowledgements
Maqueda-Palau M, et al. Physical compatibility of amiodarone in continuous infusion. Enferm Clin 2011;21:25-29
References and/or AcknowledgementsNo conflict of interest.
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