pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2021-9-4-266-277pmedpharm-878Research ArticleФАРМАЦЕВТИЧЕСКАЯ И ТОКСИКОЛОГИЧЕСКАЯ ХИМИЯPHARMACEUTICAL AND TOXICOLOGICAL CHEMISTRYРАЗРАБОТКА И ВАЛИДАЦИЯ МЕТОДИКИ КОЛИЧЕСТВЕННОГО ОПРЕДЕЛЕНИЯ АКТИВНЫХ ФАРМАЦЕВТИЧЕСКИХ СУБСТАНЦИЙ В СПРЕЕ НАЗАЛЬНОМDEVELOPMENT AND VALIDATION OF METHODS FOR QUANTITATIVE DETERMINATION OF ACTIVE PHARMACEUTICAL SUBSTANCES IN NASAL SPRAYhttps://orcid.org/0000-0001-9724-1799ЛарскийМ. В.LarskiyM. V.

кандидат фармацевтических наук, доцент кафедры фармацевтической химии

Candidate of Sciences (Pharmacy), Head of the Department of Pharmaceutical Chemistry

larsky.mikhail@gmail.comhttps://orcid.org/0000-0003-0328-0127ПоздняковаА. Е.PozdnyakovaA. E.

аспирант кафедры фармацевтической технологии с курсом медицинской биотехнологии

Post-graduate student of the Department of Pharmaceutical Technology with a course in Medical Biotechnology

techno.nastya2015@yandex.ruhttps://orcid.org/0000-0001-9724-1799ХаджиеваЗ. Д.KhadzhievaZ. D.

доктор фармацевтических наук, профессор, профессор кафедры фармацевтической технологии с курсом медицинской биотехнологии

Doctor of Sciences (Pharmacy), Professor, Professor of the Department of Pharmaceutical Technology with a course in medical biotechnology

Zara-farm@mail.ruhttps://orcid.org/0000-0002-5595-8182ПоздняковД. И.PozdnyakovD. I.

кандидат фармацевтических наук, доцент кафедры фармакологии с курсом клинической фармакологии

Candidate of Sciences (Pharmacy), Associate Professor of the Department of Pharmacology with a Course in Clinical Pharmacology

pozdniackow.dmitry@yandex.ruПятигорский медико-фармацевтический институт – филиал федерального государственного бюджетного образовательного учреждения Высшего образования «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации 357532, Россия, Ставропольский край, г. Пятигорск, пр. Калинина, 11РоссияPyatigorsk Medical and Pharmaceutical Institute – a branch of Volgograd State Medical University 11, Kalinin Av., Pyatigorsk, Russia, 357532Russian Federation20210609202194266277Copyright © Ларский М.В., Позднякова А.Е., Хаджиева З.Д., Поздняков Д.И., 20212021Ларский М.В., Позднякова А.Е., Хаджиева З.Д., Поздняков Д.И.Larskiy M.V., Pozdnyakova A.E., Khadzhieva Z.D., Pozdnyakov D.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/878

Перспективным подходом к лечению аллергического ринита может стать интраназальное введение блокаторов Н1-гистаминовых рецепторов. Ранее был разработан оригинальный состав спрея назального, содержащего фексофенадина гидрохлорид и аммония глицирризинат, демонстрирующий высокий уровень терапевтической эффективности.

Цель состояла в разработке и валидации методики количественного определения активных фармацевтических субстанций фексофенадина гидрохлорида и аммония глицирризината в спрее для интраназального введения.

Материалы и методы

Материалы и методы. В ходе разработки и валидации методики количественного определения фексофенадина гидрохлорида и аммония глицирризината в спрее назальном применялся метод высокоэффективной жидкостной хроматографии: хроматограф с УФ детектором DionexUltimate 3000 с колонкой Luna C18 (2), содержащей в качестве сорбента октадецилсиликагель с зернением 5 мкм. Анализ и валидационные процедуры выполнялись в соответствии с требованиями Государственной Фармакопеи Российской Федерации XIV издания.

Результаты

Результаты. Исследование показало, что для количественного определения при совместном присутствии фексофенадина гидрохлорида и аммония глицирризината оптимальным является градиентный режим элюирования с составом подвижной фазы 50 ммоль/л раствор калия дигидрофосфата и метанолом (45:55), который обеспечивал разделение компонентов смеси в интервале 20 минут. Валидационная оценка показала, что разработанная методика отвечает всем критериям валидности по показателям: правильность, прецизионность, специфичность и линейность в аналитической области.

Заключение

Заключение. Полученные результаты свидетельствуют о возможности использования метода высокоэффективной жидкостной хроматографии в градиентном режиме элюирования с составом подвижной фазы 50 ммоль/л раствор калия дигидрофосфата с метанолом (45:55) для количественного определения активных фармацевтических субстанций – фексофенадина гидрохлорида и аммония глицирризината в составе перспективного спрея назального для лечения аллергического ринита.

Intranasal administration of H1-histamine receptor blockers may be a promising approach to the treatment of allergic rhinitis. Earlier, an original composition of a nasal spray containing fexofenadine hydrochloride and ammonium glycyrrhizinate and demonstrating a high level of therapeutic efficacy, was developed.

The aim of the study was to develop and validate a method of the quantitative determination of active pharmaceutical ingredients fexofenadine hydrochloride and ammonium glycyrrhizinate in a spray for intranasal administration.

Materials and methods

Materials and methods. During the development and validation of the method of the fexofenadine hydrochloride and ammonium glycyrrhizinate quantitative determination in a nasal spray, the method of high performance liquid chromatography was used: a Dionex Ultimate 3000 UV chromatograph with a Luna C18 column (2) containing octadecylsilicagel with a 5 μm grain size as a sorbent. The analysis and validation procedures were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, the XIVth edition.

Results

Results. The study showed that for the simultaneous quantitative determination of fexofenadine hydrochloride and ammonium glycyrrhizinate, the optimal elution regime is a gradient mode with a mobile phase containing 50 mmol/L potassium dihydrogen phosphate solution with methanol (45:55), which ensured the separation of the components in the 20 minutes interval. The validation procedures showed that the developed methodology correspond to all the criteria of validity in terms of the following indicators: correctness, precision, specificity and linearity in the analytical area.

Conclusion

Conclusion. The obtained results indicate the possibility of using the method of high-performance liquid chromatography in a gradient elution mode with a mobile phase of the composition of a 50 mmol/L solution of potassium dihydrogen phosphate with methanol (45:55) for the simultaneous quantitative determination of active pharmaceutical ingredients – fexofenadine hydrochloride and ammonium glycyrrhizinate as parts of a promising nasal spray for the allergic rhinitis treatment.

аллергический ринитколичественное определениевысокоэффективная жидкостная хроматографияфексофенадина гидрохлоридаммония глицирризинатallergic rhinitisquantificationhigh performance liquid chromatographyfexofenadine hydrochlorideammonium glycyrrhizinateИсследование выполнено в рамках проекта, поддержанного Стипендиальной программой Президента Российской Федерации молодым ученым и аспирантам, осуществляющим перспективные научные исследования и разработки по приоритетным направлениям модернизации российской экономики (конкурс СП-1044.2019.4).The study was carried out within the framework of the project supported by the Scholarship Program of the President of the Russian Federation for young scientists and post-graduate students carrying out promising research and development in priority areas of modernization of the Russian economy (SP-1044.2019.4).ReferencesZuberbier T., Lotvall J., Simoens S., Subramanian S.V., Church M.K. 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The authors declare that there are no conflicts of interest present.