Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography
Introduction. 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 t...
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2020-05-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/763 |
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| author | Yu. M. Domnina V. V. Suslov S. A. Kedik E. V. Vorfolomeeva A. V. Meleshko |
| author_facet | Yu. M. Domnina V. V. Suslov S. A. Kedik E. V. Vorfolomeeva A. V. Meleshko |
| author_sort | Yu. M. Domnina |
| collection | DOAJ |
| description | Introduction. 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. |
| format | Article |
| id | doaj-art-0b37a2bdc4004cb282a834d5c7cc4f05 |
| institution | Matheson Library |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2020-05-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-0b37a2bdc4004cb282a834d5c7cc4f052025-08-03T19:23:56ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492020-05-01929810410.33380/2305-2066-2020-9-2-98-104730Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid ChromatographyYu. M. Domnina0V. V. Suslov1S. A. Kedik2E. V. Vorfolomeeva3A. V. Meleshko4Federal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»; JSC «Institute of Pharmaceutical Technologies»Federal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»; JSC «Institute of Pharmaceutical Technologies»Federal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»; JSC «Institute of Pharmaceutical Technologies»Federal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»; JSC «Institute of Pharmaceutical Technologies»Federal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»; JSC «Institute of Pharmaceutical Technologies»Introduction. 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.https://www.pharmjournal.ru/jour/article/view/763nasal spraynaltrexonehigh-performance liquid chromatographyvalidationgradient mode |
| spellingShingle | Yu. M. Domnina V. V. Suslov S. A. Kedik E. V. Vorfolomeeva A. V. Meleshko Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography Разработка и регистрация лекарственных средств nasal spray naltrexone high-performance liquid chromatography validation gradient mode |
| title | Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography |
| title_full | Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography |
| title_fullStr | Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography |
| title_full_unstemmed | Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography |
| title_short | Quantitative Determination of Naltrexone Hydrochloride in a Nasal Spray by High-performance Liquid Chromatography |
| title_sort | quantitative determination of naltrexone hydrochloride in a nasal spray by high performance liquid chromatography |
| topic | nasal spray naltrexone high-performance liquid chromatography validation gradient mode |
| url | https://www.pharmjournal.ru/jour/article/view/763 |
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