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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 custom-type="elpub" pub-id-type="custom">pharmjournal-164</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>АНАЛИТИЧЕСКИЕ МЕТОДИКИ И МЕТОДЫ КОНТРОЛЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ANALYTICAL AND QUALITY CONTROL METHODS</subject></subj-group></article-categories><title-group><article-title>ВАЛИДАЦИЯ МЕТОДИКИ КОЛИЧЕСТВЕННОГО ОПРЕДЕЛЕНИЯ ЛХС-1208 В ЛИОФИЛИЗИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМЕ</article-title><trans-title-group xml:lang="en"><trans-title>VALIDATION OF METHODS OF QUANTITATIVE DETERMINATION LHS-1208 IN THE LYOPHILIZED DOSAGE FORM</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>Гулякин</surname><given-names>И. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Gulyakin</surname><given-names>I. D.</given-names></name></name-alternatives><email xlink:type="simple">ilya.gulyakin@yandex.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>Николаева</surname><given-names>Л. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Nikolaeva</surname><given-names>L. L.</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>Дмитриева</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Dmitrieva</surname><given-names>M. V.</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>Оборотова</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Oborotova</surname><given-names>N. A.</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>Игнатьева</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Ignatieva</surname><given-names>E. V.</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>Дмитричева</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Dmitricheva</surname><given-names>N. A.</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>Ярцева</surname><given-names>И. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Yartseva</surname><given-names>I. V.</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>Шпрах</surname><given-names>З. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Shprakh</surname><given-names>Z. S.</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>Федеральное государственное бюджетное учреждение «Российский онкологический научный центр им. Н.Н. Блохина» Министерства здравоохранения Российской Федерации</institution></aff><aff xml:lang="en"><institution>Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>09</day><month>01</month><year>2019</year></pub-date><volume>0</volume><issue>4</issue><fpage>118</fpage><lpage>122</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Гулякин И.Д., Николаева Л.Л., Дмитриева М.В., Оборотова Н.А., Игнатьева Е.В., Дмитричева Н.А., Ярцева И.В., Шпрах З.С., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Гулякин И.Д., Николаева Л.Л., Дмитриева М.В., Оборотова Н.А., Игнатьева Е.В., Дмитричева Н.А., Ярцева И.В., Шпрах З.С.</copyright-holder><copyright-holder xml:lang="en">Gulyakin I.D., Nikolaeva L.L., Dmitrieva M.V., Oborotova N.A., Ignatieva E.V., Dmitricheva N.A., Yartseva I.V., Shprakh Z.S.</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/164">https://www.pharmjournal.ru/jour/article/view/164</self-uri><abstract><p>С целью обеспечения достоверных и точных результатов авторами проведена процедура валидации разработанной методики спектрофотометрического количественного определения действующего вещества для лиофилизированной липосомальной лекарственной формы отечественного гидрофобного противоопухолевого соединения из группы производных индолокарбазолов - ЛХС-1208. По результатам установления специфичности, линейности, диапазона применения, правильности и прецизионности валидированная методика может применяться в диапазоне 80-120% концентрации ЛХС-1208 в лекарственной форме.</p></abstract><trans-abstract xml:lang="en"><p>In order to ensure reliable and accurate results, the authors carried out the validation procedure developed technique for spectrophotometric quantification of the active substance for the lyophilized liposomal formulation of national hydrophobic antitumor compounds from the group of indolocarbazole - LHS-1208. As a result of the establishment of the specificity, linearity, range of use, accuracy and precision of a validated method may be used in the range of 80-120% concentration LHS-1208 in the dosage form.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>ЛХС-1208</kwd><kwd>лиофилизированная лекарственная форма</kwd><kwd>спектрофотометрия</kwd><kwd>валидация</kwd></kwd-group><kwd-group xml:lang="en"><kwd>LHS-1208</kwd><kwd>lyophilized dosage form</kwd><kwd>spectrophotometry</kwd><kwd>validation</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">ОФС.1.2.1.1.0003.15 Спектрофотометрия в ультрафиолетовой и видимой областях // Государственная фармакопея, XIII изд.</mixed-citation><mixed-citation xml:lang="en">ОФС.1.2.1.1.0003.15 Спектрофотометрия в ультрафиолетовой и видимой областях // Государственная фармакопея, XIII изд.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">ОФС 1.1.0012.15 Валидация аналитических методик // Государственная фармакопея, XIII изд.</mixed-citation><mixed-citation xml:lang="en">ОФС 1.1.0012.15 Валидация аналитических методик // Государственная фармакопея, XIII изд.</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>
