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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.

About the Authors

A. S. Osipov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


O. A. Popova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


S. G. Larionova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


E. Yu. Timoshina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation


References

1. Monograph: Hydroxycarbamide Capsules. British Pharmacopoeia 2016.

2. Monograph: Hydroxycarbamide. European Pharmacopoeia. 8th ed.

3. Monograph: Hydroxycarbamide. The United States Pharmacopoeia. 39th ed.

4. Monograph: Hydroxyurea Capsules. The United States Pharmacopoeia. 39th ed.

5. Osipov AS, Nechaeva EB, Pobedin OA. Hydrophilic interaction liquid chromatography used for the analysis of hydroxycarbamide. Drug Development and Registration 2015; (2): 140–4 (in Russian).

6. Osipov AS, Nechaeva EB, Truhacheva LA. Chromatographic column with nitrile sorbent used in the analysis of hydroxycarbamide by hydrophilic interaction liquid chromatography. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2016; (3): 58–61 (in Russian).

7. Osipov AS, Nechaeva EB, Pobedin OA. Application of a chromatographic column with a diol sorbent for the analysis of platinum coordination compounds. Pharmaceutical Chemistry Journal 2013; 47(6): 51–3 (in Russian).

8. Osipov AS, Nechaeva EB. Application of chromatographic columns with nitrile and phenyl sorbents to the analysis of platinum coordination compounds. Pharmaceutical Chemistry Journal 2014; 48(8): 45–8 (in Russian).

9. Osipov AS, Nechaeva EB, Mironova MM, Kovaleva EL. Use of hydrophilic interaction liquid chromatography to separate butylhydroxyanisole isomers. Pharmaceutical Chemistry Journal 2015; 49(3): 50–2 (in Russian).

10. Osipov AS, Nechaeva EB, Truhacheva LA. Hydrophilic interaction liquid chromatography used for the analysis of organic nitrates. Drug Development and Registration 2016; (3): 108–11 (in Russian).


Review

For citations:


Osipov A.S., Popova O.A., Larionova S.G., Timoshina E.Yu. Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(2):81-84. (In Russ.)

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ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)