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

摘要

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.