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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">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-95</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>СТАНДАРТИЗАЦИЯ И КОНТРОЛЬ КАЧЕСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>STANDARDIZATION AND QUALITY CONTROL OF MEDICINES</subject></subj-group></article-categories><title-group><article-title>Применение хроматографической колонки с нитрильным сорбентом для анализа гидроксикарбамида методом хроматографии гидрофильных взаимодействий</article-title><trans-title-group xml:lang="en"><trans-title>Chromatographic column with nitrile sorbent USED in the analysis of hydroxycarbamide by hydrophilic interaction liquid chromatography</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Осипов</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Osipov</surname><given-names>A. S.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Нечаева</surname><given-names>Е. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Nechaeva</surname><given-names>E. B.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Трухачева</surname><given-names>Л. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Truhacheva</surname><given-names>L. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Научный центр экспертизы средств медицинского применения</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>3</issue><fpage>58</fpage><lpage>61</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Осипов А.С., Нечаева Е.Б., Трухачева Л.А., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Осипов А.С., Нечаева Е.Б., Трухачева Л.А.</copyright-holder><copyright-holder xml:lang="en">Osipov A.S., Nechaeva E.B., Truhacheva L.A.</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.vedomostincesmp.ru/jour/article/view/95">https://www.vedomostincesmp.ru/jour/article/view/95</self-uri><abstract><p>Исследована возможность применения хроматографической колонки Zorbax SB CN 150´4,6 мм (5 мкм) для разделения смеси гидроксикарбамида (гидроксимочевины) и его примеси мочевины. В качестве подвижных фаз применяли смеси ацетонитрила и воды. Разделение анализируемых соединений на нитрильных колонках в условиях жидкостной хроматографии гидрофильных взаимодействий возможно при содержании ацетонитрила в подвижной фазе более 90 %. При хроматографировании на нитрильной колонке Zorbax SB CN наблюдалось изменение очередности элюирования гидроксикарбамида и мочевины по сравнению с элюированием на аминоколонке Zorbax NH2.</p></abstract><trans-abstract xml:lang="en"><p>The possibility of using chromatographic columns Zorbax SB CN 150´4,6 mm (5 μm) for separation of hydroxycarbamide (hydroxyurea) and its impurity urea has been investigated. The mixture of acetonitrile and water has been used as a mobile phase used. Separation of analytes on nitrile columns under the conditions of hydrophilic interaction liquid chromatography is possible only when the content of acetonitrile in the mobile phase is more than 90 %. When performing chromatographic procedure with Zorbax SB CN on nitrile column, the change in elution order of hydroxycarbamide and urea has been detected, compared to the elution order on amino column Zorbax NH2.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>высокоэффективная жидкостная хроматография</kwd><kwd>хроматография гидрофильных взаимодействий</kwd><kwd>гидроксикарбамид (гидроксимочевина)</kwd><kwd>нитрильный сорбент</kwd><kwd>фармакопея</kwd><kwd>high-performance liquid chromatography</kwd><kwd>hydrophilic interaction liquid chromatography</kwd><kwd>hydroxycarbamide (hydroxyurea)</kwd><kwd>nitrile sorbent</kwd><kwd>pharmacopoeia</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">British Pharmacopoeia 2012. Monograph: Hydroxycarbamide Capsules.</mixed-citation><mixed-citation xml:lang="en">British Pharmacopoeia 2012. Monograph: Hydroxycarbamide Capsules.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">European Pharmacopoeia. Edition 8.0. Monograph : Hydroxycarbamide.</mixed-citation><mixed-citation xml:lang="en">European Pharmacopoeia. Edition 8.0. Monograph : Hydroxycarbamide.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">The United States Pharmacopoeia 38. Monograph: Hydroxyurea.</mixed-citation><mixed-citation xml:lang="en">The United States Pharmacopoeia 38. Monograph: Hydroxyurea.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">The United States Pharmacopoeia 38. Monograph: Hydroxyurea Capsules.</mixed-citation><mixed-citation xml:lang="en">The United States Pharmacopoeia 38. Monograph: Hydroxyurea Capsules.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Осипов АС, Нечаева ЕБ, Победин ОА. Применение жидкостной хроматографии гидрофильных взаимодействий для анализа гидроксикарбамида. Разработка и регистрация лекарственных средств 2015; (2): 140-4.</mixed-citation><mixed-citation xml:lang="en">Osipov AS, Nechaeva EB, Pobedin OA. The use of hydrophilic interaction liquid  chromatography for analysis of hydroxyurea. Razrabotka i registratsiya lekarstvennyh  sredstv 2015; (2): 140–4 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Осипов АС, Нечаева ЕБ, Победин ОА. Применение хроматографической колонки с диольным сорбентом для анализа координационных соединений платины. Химико-фармацевтический журнал 2013; 47(6): 51-3.</mixed-citation><mixed-citation xml:lang="en">Osipov AS, Nechaeva EB, Pobedin OA. The use of column chromatography with diol  sorbent for analysis of diesel platinum coordination compounds. Himiko- farmatsevticheskiy zhurnal 2013; 47(6): 51–3 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Осипов АС, Нечаева ЕБ. Применение хроматографических колонок с нитрильными и фенильными сорбентами для анализа координационных соединений платины. Химико-фармацевтический журнал 2014; 48(8): 45-8.</mixed-citation><mixed-citation xml:lang="en">Osipov AS, Nechaeva EB. The use of chromatographic columns with nitrile and phenyl  sorbents for the analysis of coordination compounds of platinum. Himiko- farmatsevticheskiy zhurnal 2014; 48(8): 45–8 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Осипов АС, Нечаева ЕБ, Миронова ММ, Ковалева ЕЛ. Применение жидкостной хроматографии гидрофильных взаимодействий для разделения изомеров бутилгидроксианизола. Химико-фармацевтический журнал 2015; 49(3): 50-2.</mixed-citation><mixed-citation xml:lang="en">Osipov AS, Nechaeva EB, Mironova MM, Kovaleva EL. The use of liquid chromatography  of hydrophilic interactions for separation of butylhydroxyanisole isomers. Himiko- farmatsevticheskiy zhurnal 2015; 49(3): 50–2 (in Russian).</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
