Forced degradation studies of new formulation containing naltrexone

Authors : Golnaz YAGHOUBNEZHADZANGANEH, E Vildan BURGAZ

Pages : 75-83

View : 19 | Download : 9

Publication Date : 2019-12-30

Article Type : Research Paper

Abstract :Naltrexone is one of the classical opioid antagonists. In substantially lower than standard doses, they apply different pharmacodynamics. A daily dose of 1 to 5 mg is considered as low-dose naltrexone insert ignore into journalissuearticles values(LDN);. Clinical reports of LDN have demonstrated its possible benefits in diseases such as fibromyalgia, Crohn’s disease, multiple sclerosis, complex-regional pain syndrome, Hailey-Hailey disease, and cancer. The aim of the present study was to establish the inherent stability of naltrexone and stability indicating assay method for simultaneous determination of naltrexone after being subjected to acidic and basic stress. A forced degradation study of naltrexone in its tablet form was conducted under the acidic and basicconditions in order to develop a rapid and sensitive stability indicating UV-Visible method for the quantification of naltrexone. Quantification was achieved by UV detection at 286.60 nm, on the basis of peak area. Naltrexone was found to be unstable and degraded in the acidic and basic buffer up to 3 hours. 
Keywords : Forced Degradation, Low Dose Naltrexone, Naltrexone