Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea

The article investigates the possibility of using the chromatographic column XBridge Amide 150´4.6 mm (3.5 μm) for separation of hydroxycarbamide (hydroxyurea) and its impurity (urea). The mobile phases used were the mixtures of acetonitrile and water. The separation of analytes on an amide column b...

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Main Authors: A. S. Osipov, O. A. Popova, S. G. Larionova, E. Yu. Timoshina
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/123
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author A. S. Osipov
O. A. Popova
S. G. Larionova
E. Yu. Timoshina
author_facet A. S. Osipov
O. A. Popova
S. G. Larionova
E. Yu. Timoshina
author_sort A. S. Osipov
collection DOAJ
description The article investigates the possibility of using the chromatographic column XBridge Amide 150´4.6 mm (3.5 μm) for separation of hydroxycarbamide (hydroxyurea) and its impurity (urea). The mobile phases used were the mixtures of acetonitrile and water. The separation of analytes on an amide column by hydrophilic interaction liquid chromatography is feasible if the proportion of acetonitrile in the mobile phase accounts for more than 93 %. When performing chromatographic separation on the amide column XBridge Amide, a change in the elution order of hydroxycarbamide and urea was observed, as compared to the elution on nitrile and diol columns. This type of columns can be used for chromatographic separation of a mixture of hydroxycarbamide and urea in order to perform system suitability testing when analyzing urea by HPLC.
format Article
id doaj-art-6b3b48ddf3ac478fac7dbc21e224587e
institution Kabale University
issn 3034-3062
3034-3453
language Russian
publishDate 2018-02-01
publisher Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
record_format Article
series Регуляторные исследования и экспертиза лекарственных средств
spelling doaj-art-6b3b48ddf3ac478fac7dbc21e224587e2025-08-20T03:40:14ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-01728184121Hydrophylic interaction chromatography used for separation of hydroxycarbamide and ureaA. S. Osipov0O. A. Popova1S. G. Larionova2E. Yu. Timoshina3Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article investigates the possibility of using the chromatographic column XBridge Amide 150´4.6 mm (3.5 μm) for separation of hydroxycarbamide (hydroxyurea) and its impurity (urea). The mobile phases used were the mixtures of acetonitrile and water. The separation of analytes on an amide column by hydrophilic interaction liquid chromatography is feasible if the proportion of acetonitrile in the mobile phase accounts for more than 93 %. When performing chromatographic separation on the amide column XBridge Amide, a change in the elution order of hydroxycarbamide and urea was observed, as compared to the elution on nitrile and diol columns. This type of columns can be used for chromatographic separation of a mixture of hydroxycarbamide and urea in order to perform system suitability testing when analyzing urea by HPLC.https://www.vedomostincesmp.ru/jour/article/view/123высокоэффективная жидкостная хроматографияжидкостная хроматография гидрофильных взаимодействийгидроксикарбамидмочевинафармакопеяhigh performance liquid chromatographyhydrophilic interaction liquid chromatographyhydroxycarbamidehydroxyureapharmacopoeia
spellingShingle A. S. Osipov
O. A. Popova
S. G. Larionova
E. Yu. Timoshina
Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
Регуляторные исследования и экспертиза лекарственных средств
высокоэффективная жидкостная хроматография
жидкостная хроматография гидрофильных взаимодействий
гидроксикарбамид
мочевина
фармакопея
high performance liquid chromatography
hydrophilic interaction liquid chromatography
hydroxycarbamide
hydroxyurea
pharmacopoeia
title Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
title_full Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
title_fullStr Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
title_full_unstemmed Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
title_short Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
title_sort hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
topic высокоэффективная жидкостная хроматография
жидкостная хроматография гидрофильных взаимодействий
гидроксикарбамид
мочевина
фармакопея
high performance liquid chromatography
hydrophilic interaction liquid chromatography
hydroxycarbamide
hydroxyurea
pharmacopoeia
url https://www.vedomostincesmp.ru/jour/article/view/123
work_keys_str_mv AT asosipov hydrophylicinteractionchromatographyusedforseparationofhydroxycarbamideandurea
AT oapopova hydrophylicinteractionchromatographyusedforseparationofhydroxycarbamideandurea
AT sglarionova hydrophylicinteractionchromatographyusedforseparationofhydroxycarbamideandurea
AT eyutimoshina hydrophylicinteractionchromatographyusedforseparationofhydroxycarbamideandurea