Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea
Abstract
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.
