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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">pharmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Разработка и регистрация лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Drug development &amp; registration</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2305-2066</issn><issn pub-type="epub">2658-5049</issn><publisher><publisher-name>LLC «CPHA»</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.33380/2305-2066-2025-14-4-2170</article-id><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-2221</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>МЕТОДЫ АНАЛИЗА ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ANALYTICAL METHODS</subject></subj-group></article-categories><title-group><article-title>Разработка и валидация ВЭЖХ-методики количественного определения кумарина в бобах тонка</article-title><trans-title-group xml:lang="en"><trans-title>Development and validation of a HPLC-method for the quantitative determination of coumarin in tonka beans</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0001-9938-1549</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шуракова</surname><given-names>В. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Shurakova</surname><given-names>V. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, ул. Профессора Попова, д. 14, литера А</p></bio><bio xml:lang="en"><p>14A, Prof. Popova str., Saint-Petersburg, 197022</p></bio><email xlink:type="simple">valeriya.shurakova@spcpu.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7005-2477</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сурбеева</surname><given-names>Е. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Surbeeva</surname><given-names>E. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, ул. Профессора Попова, д. 14, литера А</p></bio><bio xml:lang="en"><p>14A, Prof. Popova str., Saint-Petersburg, 197022</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7977-1080</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Стрелков</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Strelkov</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, ул. Профессора Попова, д. 14, литера А</p></bio><bio xml:lang="en"><p>14A, Prof. Popova str., Saint-Petersburg, 197022</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2942-1015</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тернинко</surname><given-names>И. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Terninko</surname><given-names>I. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>197022, г. Санкт-Петербург, ул. Профессора Попова, д. 14, литера А</p></bio><bio xml:lang="en"><p>14A, Prof. Popova str., Saint-Petersburg, 197022</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный химико-фармацевтический университет» Министерства здравоохранения Российской Федерации (ФГБОУ ВО СПХФУ Минздрава России)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint-Petersburg State Chemical and Pharmaceutical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>03</day><month>12</month><year>2025</year></pub-date><volume>14</volume><issue>4</issue><fpage>164</fpage><lpage>173</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Шуракова В.С., Сурбеева Е.С., Стрелков С.В., Тернинко И.И., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Шуракова В.С., Сурбеева Е.С., Стрелков С.В., Тернинко И.И.</copyright-holder><copyright-holder xml:lang="en">Shurakova V.S., Surbeeva E.S., Strelkov S.V., Terninko I.I.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmjournal.ru/jour/article/view/2221">https://www.pharmjournal.ru/jour/article/view/2221</self-uri><abstract><sec><title>Введение</title><p>Введение. Бобы тонка (семена Dipteryx odorata, семейство Fabaceae) – ценный источник кумарина, применяемого в пищевой, парфюмерной и косметической промышленности благодаря насыщенному аромату. Несмотря на фармакологическую ценность (антикоагулянтная, антиоксидантная активность), кумарин обладает доказанной гепато- и гематотоксичностью, что ограничивает его использование в ряде стран. Несмотря на контроль синтетического кумарина в ароматизаторах, природный аналог из бобов тонка не имеет четких нормативов, хотя обладает идентичной активностью. Рост спроса на натуральные продукты повысил популярность бобов тонка, однако недостаток научных данных об их безопасности и методах анализа затрудняет контроль качества. Разработка валидированных методик анализа с использованием метода ВЭЖХ – актуальная задача для обеспечения безопасности его применения в промышленности.</p></sec><sec><title>Цель</title><p>Цель. Разработка ВЭЖХ-методики количественного определения кумарина в бобах тонка и ее валидация с дальнейшей апробацией на нескольких партиях исследуемого объекта.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. В качестве объектов исследования были использованы пять партий бобов тонка различных стран-производителей. Условия хроматографирования: колонка Luna C18(100) Å LC Column, 250 × 4,6 мм, 5 мкм, температура термостата – 40 °С, длина волны детекции – 275 нм, ПФ А – ацетонитрил, ПФ Б – вода. Режим элюирования: изократика (ПФ Б – 50 %) в течение 12 мин.</p></sec><sec><title>Результаты и обсуждение</title><p>Результаты и обсуждение. Разработанная методика валидна по показателям пригодности хроматографической системы, специфичности, линейности (диапазон 0,001–0,1 мг/мл) и прецизионности. Ее преимущества – экспрессность и экономичность, что упрощает контроль качества сырья. Количественное содержание кумарина в исследуемых объектах варьируется в диапазоне от 1,25 ± 0,07 % до 4,29 ± 0,12 %, что коррелирует с данными зарубежных исследователей.</p></sec><sec><title>Заключение</title><p>Заключение. Разработана и валидирована ВЭЖХ-методика для количественного определения кумарина в бобах тонка. Разработанная методика может быть использована для стандартизации и рутинного анализа этого перспективного сырья в различных отраслях промышленности, обеспечивая необходимый уровень безопасности при его применении.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. The tonka beans (seeds of Dipteryx odorata, family Fabaceae) is a valuable source of coumarin used in the food, perfume and cosmetic industries thanks to its rich aroma. Despite its pharmacological value (anticoagulant, antioxidant activity), coumarin has a proven hepatotoxicity and haematotoxicity, which limits its use in a number of countries. Despite the control of synthetic coumarin in aromatics, the natural analog of tunica beans does not have clear rules, although it has identical activity. Growing demand for organic products has increased the popularity of tonka beans, but lack of scientific data on their safety and methods of analysis makes quality control difficult. The development of validated techniques, such as HVACR, is an urgent task to ensure the safety of its application in industry.</p></sec><sec><title>Aim</title><p>Aim. Development of a HPLC-method for the quantitative determination of coumarin in beans and its validation with further testing on several batches of the studied object.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. Five batches of Tonka beans from different producing countries were purchased as research objects, for sample preparation was used US-bath. Chromatography conditions: Luna 5 μm C18(100) Å LC Column 250 × 4.6 mm, thermostat temperature – 40 °C, detection wavelength – 275 nm. Mobile phase A – acetonitrile, mobile phase B – water. Elution mode: isocratic mobile phase B – 50 % for 12 minutes.</p></sec><sec><title>Results and discussion</title><p>Results and discussion. The method meets the criteria of suitability of the chromatographic system, specificity, linearity (range 0.001–0.1 mg/ml) and precision. Its advantages are expressiveness and economy, which simplifies the quality control of raw materials. The quantitative content of coumarin in the studied object ranges from 1.25 ± 0.07 % to 4.29 ± 0.12 %.</p></sec><sec><title>Conclusion</title><p>Conclusion. Developed and validated by HPLC-methodology for the quantitative determination of coumarin in tonka beans. The developed methodology can be used to standardize this promising raw material in various industries, ensuring the necessary level of safety in its application.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>кумарин</kwd><kwd>бобы тонка</kwd><kwd>ВЭЖХ-методика</kwd><kwd>валидация</kwd><kwd>количественное определение</kwd></kwd-group><kwd-group xml:lang="en"><kwd>coumarin</kwd><kwd>beans thin</kwd><kwd>HPLC-method</kwd><kwd>validation</kwd><kwd>quantitative determination</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Анализ выполнен на базе центра коллективного пользования (ЦКП) «Аналитический центр» ФГБОУ ВО СПХФУ Минздрава России.</funding-statement><funding-statement xml:lang="en">The analysis was carried out on the basis of the Collective Use Center (CUС) "Analytical Center" of the Federal State Budgetary Educational Institution of Higher Education (SPCPU) of the Ministry of Health of Russia.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Cuchet A., Jame P., Anchisi A., Schiets F., Carénini E., Casabianca H. 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