LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY METHOD TO ASSESS NALOXONE HYDROCHLORIDE PHOTOSTABILITY UNDER ARTIFICIAL LIGHT AND SUNLIGHT EXPOSURE AT ROOM TEMPERATURE
Abstract
Objectives: Naloxone is an opioid antagonist indicated for central nervous system and respiratory depression treatment induced by natural or
synthetic opioid in adults and neonates whose mothers have received opioids. Although naloxone hydrochloride has been reported to be physically
and chemically stable, photostability of naloxone hydrochloride under artificial light, and sunlight has not been reported. Therefore, a method was
required for assessment of naloxone hydrochloride photostability.
Methods: A high-performance liquid chromatography/mass spectrometry method was established to evaluate the photostability of naloxone
hydrochloride. Injections of naloxone hydrochloride in 0.9% sodium chloride were exposed to artificial light and sunlight at room temperature for
192 hrs.
Results: Naloxone losses up to 5.26% of its initial concentration when exposed to artificial light at room temperature for 192 hrs, but the degradation
increased up to 15.08% under sunlight exposure at room temperature for 192 hrs. The disappearance of naloxone hydrochloride was correlated with
the appearance of noroxymorphone degradant.
Conclusion: Naloxone hydrochloride is photosensitive and degradation increased as the light intensity increased. Therefore, naloxone intravenous
infusion solutions should either be protected from light and/or be frequently replaced when being administered to patients.
Keywords: Liquid chromatography/mass spectrometry, Naloxone hydrochloride, Photostability, Noroxymorphone, Intravenous infusion, Electrospray
ionization.
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