LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY METHOD TO ASSESS NALOXONE HYDROCHLORIDE PHOTOSTABILITY UNDER ARTIFICIAL LIGHT AND SUNLIGHT EXPOSURE AT ROOM TEMPERATURE

Objectives: Naloxone is an opioid antagonist indicated for central nervous system and respiratory depression treatment induced by natural orsynthetic opioid in adults and neonates whose mothers have received opioids. Although naloxone hydrochloride has been reported to be physicallyand chemically stable, photostability of naloxone hydrochloride under artificial light, and sunlight has not been reported. Therefore, a method wasrequired for assessment of naloxone hydrochloride photostability.Methods: A high-performance liquid chromatography/mass spectrometry method was established to evaluate the photostability of naloxonehydrochloride. Injections of naloxone hydrochloride in 0.9% sodium chloride were exposed to artificial light and sunlight at room temperature for192 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 degradationincreased up to 15.08% under sunlight exposure at room temperature for 192 hrs. The disappearance of naloxone hydrochloride was correlated withthe appearance of noroxymorphone degradant.Conclusion: Naloxone hydrochloride is photosensitive and degradation increased as the light intensity increased. Therefore, naloxone intravenousinfusion 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, Electrosprayionization