METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE
Abstract
Method of determination of potassium cyanate in carbamylated darbepoietin alpha drug substance was developed. The method is based on derivatization of cyanate by methyl ester of anthranilic acid followed by formation bicyclic derivative (1-H,3-H-quinazolinedione), which is able to fluorescence. Application of this method to determine potassium cyanate in protein drugs was investigated. Interference of excipients on this method was evaluated. The validation was performed: specificity, linearity, accuracy, precision, limit of quantitication.
About the Authors
A. D. Askretkov
Moscow Technological University (MITHT)
Russian Federation
Russian Federation
M. A. Zhuchenko
Scientific Center of Russian Federation «Research Institute for Genetics and Selection of Industrial Microorganisms»
Russian Federation
Russian Federation
N. V. Orlova
Scientific Center of Russian Federation «Research Institute for Genetics and Selection of Industrial Microorganisms»
Russian Federation
Russian Federation
References
1. 10 ведущих причин смерти в мире. Информационный бюллетень / Всемирная организация здравоохранения. Январь, 2017. URL: http://www.who.int/mediacentre/factsheets/fs310/ru/ (дата обращения 07.06.2017).
2. R.A. Gottlieb. Cell Death Pathways in Acute I/R Injury // J. Cardiovasc. Pharmacol. Ther. 2011. V. 16(3-4). P. 233-238.
3. W. Jelkman. Regulation of erythropoietin production // J. Physiol.2011. V. 589. P. 1251-1258.
4. J. Minnerup, H. Wersching, W-R. Schäbitzet al. Erythropoietin for stroke treatment: dead or alive? // Crit. Care. 2011. V. 15 (2). P. 129.
5. Патент РФ № 2575773. Карбамилированный дарбэпоэтин 9с-depo, способ его получения и применение его в качестве лекарственного средства с цитопротекторным действием / Р.Р. Шукуров, Р.Р. Хамитов, И.С. Кряжевских; патентообладатель ООО «Фармапарк». - № 2013131194/15; заявл. 09.07.2013, опубл. 20.02.2016. Бюл. № 5.
6. Р.Р. Шукуров, Н.В. Лобанова, И.Н. Савинова и др. Создание стабильной клеточной линии-продуцента рекомбинантного дарбэпоэтина-альфа на основе клеток СНО // Биотехнология. 2013. № 2. С. 46-54.
7. А.А. Нурбаков, Н.В. Лобанова, И.Н. Савинова и др. Оптимизация технологии культивирования клеток CHO, экспрессирующих рекомбинантный дарбэпоэтин-альфа, в замкнутом объеме с подпиткой // Биотехнология. 2012. № 12. С. 55-65.
8. M.A. Dorato, J.A. Engelhardt. The no-observed-adverse-effect-level in drug safety evaluations: Use, issues, and definition(s) // Regul. Toxicol. Pharmacol.2005. V. 42(3). P. 265-74.
9. Handbook of Anion Determination / W John Williams. - London: Butterworth-Heinemann, 1979. 640 p.
10. W. H. R. Shaw, J. J. Bordeaux.Semimicromethod for Determination of Cyanate Ion in Presence of Interfering Substances//Anal. Chem. 1955. V. 27(1). P. 136-138.
11. J. M. Kruse, M. G. Mellon. Colorimetric Determination of Ammonia and Cyanate // Anal. Chem. 1953. V. 25 (8). P. 1188-1192.
12. V.M. Luque-Almagro, R. Blasco, J.M. Fernández-Romero, M.D. Luque de Castro. Flow-injection spectrophotometric determination of cyanate in bioremediation processes by use of immobilised inducible cyanase // Anal. Bioanal. Chem. 2003. V. 377. P. 1071-1078.
13. M. Guilloton, F. Karst. A Spectrophotometric Determination of Cyanate Using Reaction with 2-Aminobenzoic Acid // Anal. Biochem. 1985. V. 149. P. 291-295.
14. S. Eiger, S.D. Black. Analysis of Plasma Cyanate as 2-Nitro-5-thiocarbamylbenzoic Acid by High-Performance Liquid Chromatography // Anal. Biochem. 1985. V. 146. P. 321-326.
15. T.H.K. Ohe, A.A. da Silva, T.´ıs da S.Rocha et al. A Fluorescence-Based Method For Cyanate Analysis In Ethanol/Water Media: Correlation Between Cyanate Presence And Ethyl Carbamate Formation In Sugar Cane Spirit // J. Food Sci. 2014. V. 79 (10). P. 1950-1955.
16. S.B. Black , R.S. Schulz. Ion chromatographic determination of cyanate in saline gold processing samples // J. Chromatogr. A. 1999. V. 855. P. 267-272.
17. P. Fagan, B. Paull, P.R. Haddad et al. Ion chromatographic analysis of cyanate in gold processing samples containing large concentrations of copper(I) and other metallocyanide complexes // J. Chromatogr. A. 1997. V. 770. P. 175-183.
18. P. Lundquist. B. Backmangullers.B. Kagedal. H. Rosling. Fluorometric Determination of Cyanate in Plasma by Conversion to 2,4(1H,3H)-Quinazolinedione and Separation by High-Performance Liquid Chromatography // Anal. Biochem. 1993. V. 211(1). P. 23-27.
19. B. Widner, M.R. Mulholland, K. Mopper. Chromatographic Determination of Nanomolar Cyanate Concentrations in Estuarine and Sea Waters by Precolumn Fluorescence Derivatization // Anal. Chem. 2013. V. 85 (14). P. 6661-6666.
20. Potassium cyanate ANACHEMIA MSDS Canada. Version 2.2. Prepared by MSDS Department/Département de F.S. January 2013. 4 p.
21. ОФС.1.1.0012.15. Валидация аналитических методик // Государственная фармакопея РФ. XIII изд. Т. 1. - М., 2016.
22. P. Lundquist, B. Backman-Gullers, B. Kågedal et al. Fluorometric determination of cyanate in plasma by conversion to 2,4(1H,3H)- quinazolinedione and separation by high-performance liquid chromatography // Anal. Biochem. 1993. V. 211(1). P. 23-27.
23. X. Deng, L. Guo, L.Xu et al. Discovery of Novel Potent and Selective Ligands for 5-HT2A Receptor with Quinazoline Scaffold // Bioorg. Med. Chem. Lett. 2015. V. 25(18). P. 3970-3974.
Review
For citations:
Askretkov A.D., Zhuchenko M.A., Orlova N.V. METHOD OF FLUORIMETRIC DETERMINATION OF POTASSIUM CYANATE IN CARBAMYLATED DARBEPOIETIN ALPHA DRUG SUBSTANCE. Drug development & registration. 2017;(3):116-122. (In Russ.)
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