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 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
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
Mitchell AA. Prevalence and characteristics of opioid use in the US
adult population. Pain 2008;138(3):507-13.
2. Coluzzi F, Pappagallo M; National Initiative on Pain Control. Opioid
therapy for chronic noncancer pain: Practice guidelines for initiation
and maintenance of therapy. Minerva Anestesiol 2005;71(7-8):425-33.
3. Maxwell SR, Bateman DN. Choice of opioid analgesics in postoperative
care. Lancet 2007;369(9578):2000.
4. Myles PS, Power I. Clinical update: Postoperative analgesia. Lancet
5. Kehlet H, Holte K. Effect of postoperative analgesia on surgical
outcome. Br J Anaesth 2001;87(1):62-72.
6. Pattinson KT. Opioids and the control of respiration. Br J Anaesth
7. Jungquist CR, Karan S, Perlis ML. Risk factors for opioid-induced
excessive respiratory depression. Pain Manag Nurs 2011;12(3):180-7.
8. Chieh K, Matthias E. Respiratory effects of opioids in perioperative
medicine. Open Anesthesiol J 2011;5 Suppl 1:23-34.
9. Vila H Jr, Smith RA, Augustyniak MJ, Nagi PA, Soto RG, Ross TW,
et al. The efficacy and safety of pain management before and after
implementation of hospital-wide pain management standards: Is patient
safety compromised by treatment based solely on numerical pain
ratings? Anesth Analg 2005;101(2):474-80.
10. Centers for Disease Control and Prevention (CDC). Emergency
department visits involving nonmedical use of selected prescription
drugs - United States, 2004-2008. MMWR Morb Mortal Wkly Rep
11. McPherson M. Strategies for the management of opioid-induced
adverse effects. Adv Stud Pharm 2008;5(2):52-7.
12. Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L,
et al. American Society for Pain Management Nursing guidelines on
monitoring for opioid-induced sedation and respiratory depression.
Pain Manag Nurs 2011;12(3):118-145.e10.
13. Public Assessment Report of the Medicines Evaluation Board in the
Netherlands. Naloxone HCL-hamlen 0.4 mg/ml, solution for injection
Hamlen Pharma Plus GmbH, Germany; 2011.
14. Pillay V. Naloxone: Opening up new vistas. J Forensic Med Toxicol
15. Mycyk MB, Szyszko AL, Aks SE. Nebulized naloxone gently
and effectively reverses methadone intoxication. J Emerg Med
16. Panchagnula R, Sharma P, Khandavilli S, Varma MV. RP-HPLC
method and its validation for the determination of naloxone from a
novel transdermal formulation. Farmaco 2004;59(10):839-42.
17. Tenenbein M. Continuous naloxone infusion for opiate poisoning in
infancy. J Pediatr 1984;105(4):645-8.
18. American Academy of Pediatrics Committee on Drugs: Naloxone
dosage and route of administration for infants and children: Addendum
to emergency drug doses for infants and children. Pediatrics
19. The British Pharmacopoeia 2007. The Stationary Office (TSO).
London: Health Ministry; 2006.
20. Mostafavi A, Abedi G, Jamshidi A, Afzali D, Talebi M. Development
and validation of a HPLC method for the determination of buprenorphine
hydrochloride, naloxone hydrochloride and noroxymorphone in a tablet
formulation. Talanta 2009;77(4):1415-9.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.