Open AccessQuantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography
Author(s) -
Ю. М. Домнина,
В. В. Суслов,
С. А. Кедик,
Е. В. Ворфоломеева,
А. В. Мелешко
Publication year - 2020
Publication title -
razrabotka i registraciâ lekarstvennyh sredstv
Language(s) - English
Resource type - Journals
eISSN - 2658-5049
pISSN - 2305-2066
DOI - 10.33380/2305-2066-2020-9-2-98-104
Subject(s) - naltrexone , chromatography , nasal spray , high performance liquid chromatography , chemistry , matrix (chemical analysis) , opioid , nasal administration , pharmacology , medicine , biochemistry , receptor
. Naltrexone, an antagonist of µ-opioid receptors, is promising for the treatment of various autoimmune and oncological diseases when used in doses of 1.5–5 mg/day. To date, there are no medications that provide such dosages of naltrexone. Aim . Development and validation of a method for the quantitative determination of naltrexone hydrochloride in a nasal spray by high performance liquid chromatography (HPLC). Materials and methods . As an object of research, a naltrexone hydrochloride nasal spray was used. The quantitative determination of naltrexone in the test sample was developed using a Dionex UltiMate 3000 high-performance liquid chromatograph (Thermo Scientific, USA) equipped with a diode-matrix detector. Results and discussion . The possibility of using isocratic and gradient chromatographic modes for the quantitative determination of naltrexone hydrochloride in the nasal spray was studied. Based on these results, a new method of determination using the gradient mode is proposed, which allows minimizing the influence of the polymer component in the test sample on the analysis results. Conclusion . A new technique of high-performance liquid chromatography (HPLC) is proposed that allows identification and quantification of naltrexone hydrochloride in a nasal spray containing a high concentration of water-soluble heat-sensitive poloxamer as a thickener. The developed method was validated according to the parameters: correctness, precision, specificity, linearity.