Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis
Introduction. Recently, there has been a growing trend in the number of obese and overweight patients. To date, sibutramine is the most effective drug for treating obesity and overweight. The drug is an inhibitor of the reuptake of serotonin and norepinephrine, which leads to a decrease in hunger, a...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2020-11-01
|
| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/851 |
| _version_ | 1797874964235288576 |
|---|---|
| author | A. M. Sukhanova I. B. Perova K. I. Eller G. M. Rodionova S. V. Chernova V. N. Kuzina |
| author_facet | A. M. Sukhanova I. B. Perova K. I. Eller G. M. Rodionova S. V. Chernova V. N. Kuzina |
| author_sort | A. M. Sukhanova |
| collection | DOAJ |
| description | Introduction. Recently, there has been a growing trend in the number of obese and overweight patients. To date, sibutramine is the most effective drug for treating obesity and overweight. The drug is an inhibitor of the reuptake of serotonin and norepinephrine, which leads to a decrease in hunger, and therefore, to weight loss.Aim. To develop and validate a methodology for the determination of sibutramine in drugs by capillary electrophoresis (CE) using an ultraviolet diode array detector.Materials and methods. Quantitative determination of sibutramine in drugs was carried out using the CE method with an ultraviolet diode array detector. A solution of phosphate buffer 50 mmol pH = 7.0 was used as a solvent and working electrolyte; to separate the peaks – quartz capillary 56 cm, 50 μm.Results and discussion. The developed method was validated according to the following parameters: specificity, linearity, correctness, precision, limit of detection and limit of quantification.Conclusion. A method for the quantitative determination of sibutramine in drugs by the CE method using an ultraviolet diode array detector has been developed and validated. This method meets all the requirements of General Pharmacopoeia Monograph 1.1.0012.15 «Validation of the analytical method» and can be used to control the quality of drugs, the active pharmaceutical substance of which is sibutramine. |
| first_indexed | 2024-04-10T01:39:12Z |
| format | Article |
| id | doaj.art-73a4b5854474497b8aa5bcdef091d0cd |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2024-04-10T01:39:12Z |
| publishDate | 2020-11-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-73a4b5854474497b8aa5bcdef091d0cd2023-03-13T09:14:01ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492020-11-019414114510.33380/2305-2066-2020-9-4-141-145787Development and Validation of Sibutramine Determination in Drug Products by Capillary ElectrophoresisA. M. Sukhanova0I. B. Perova1K. I. Eller2G. M. Rodionova3S. V. Chernova4V. N. Kuzina5ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский Университет); ФГБУН «ФИЦ питания, биотехнологии и безопасности пищи»ФГБУН «ФИЦ питания, биотехнологии и безопасности пищи»ФГБУН «ФИЦ питания, биотехнологии и безопасности пищи»ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский Университет)ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский Университет)ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский Университет)Introduction. Recently, there has been a growing trend in the number of obese and overweight patients. To date, sibutramine is the most effective drug for treating obesity and overweight. The drug is an inhibitor of the reuptake of serotonin and norepinephrine, which leads to a decrease in hunger, and therefore, to weight loss.Aim. To develop and validate a methodology for the determination of sibutramine in drugs by capillary electrophoresis (CE) using an ultraviolet diode array detector.Materials and methods. Quantitative determination of sibutramine in drugs was carried out using the CE method with an ultraviolet diode array detector. A solution of phosphate buffer 50 mmol pH = 7.0 was used as a solvent and working electrolyte; to separate the peaks – quartz capillary 56 cm, 50 μm.Results and discussion. The developed method was validated according to the following parameters: specificity, linearity, correctness, precision, limit of detection and limit of quantification.Conclusion. A method for the quantitative determination of sibutramine in drugs by the CE method using an ultraviolet diode array detector has been developed and validated. This method meets all the requirements of General Pharmacopoeia Monograph 1.1.0012.15 «Validation of the analytical method» and can be used to control the quality of drugs, the active pharmaceutical substance of which is sibutramine.https://www.pharmjournal.ru/jour/article/view/851сибутраминкэлекарственные препаратыколичественное определениевалидация |
| spellingShingle | A. M. Sukhanova I. B. Perova K. I. Eller G. M. Rodionova S. V. Chernova V. N. Kuzina Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis Разработка и регистрация лекарственных средств сибутрамин кэ лекарственные препараты количественное определение валидация |
| title | Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis |
| title_full | Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis |
| title_fullStr | Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis |
| title_full_unstemmed | Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis |
| title_short | Development and Validation of Sibutramine Determination in Drug Products by Capillary Electrophoresis |
| title_sort | development and validation of sibutramine determination in drug products by capillary electrophoresis |
| topic | сибутрамин кэ лекарственные препараты количественное определение валидация |
| url | https://www.pharmjournal.ru/jour/article/view/851 |
| work_keys_str_mv | AT amsukhanova developmentandvalidationofsibutraminedeterminationindrugproductsbycapillaryelectrophoresis AT ibperova developmentandvalidationofsibutraminedeterminationindrugproductsbycapillaryelectrophoresis AT kieller developmentandvalidationofsibutraminedeterminationindrugproductsbycapillaryelectrophoresis AT gmrodionova developmentandvalidationofsibutraminedeterminationindrugproductsbycapillaryelectrophoresis AT svchernova developmentandvalidationofsibutraminedeterminationindrugproductsbycapillaryelectrophoresis AT vnkuzina developmentandvalidationofsibutraminedeterminationindrugproductsbycapillaryelectrophoresis |