Development of control procedures of related impurities in 7-(4-fluoro-benzyl)-3-tioxo-2,3-dihydro[1,2,4]triazolo[4,3-а]pyrazin-8(7Н)-one substance
DOI:
https://doi.org/10.15587/2313-8416.2016.61864Keywords:
[1, 2, 4]triazolo[4, 3-а]pyrazin, related impurities, the method of high-performance liquid chromatography, validation criteriaAbstract
Purity control of pharmaceutical substances is an essential part of the modern requirements for substances on the stage of pharmaceutical development.
Aim. The aim of research was to develop and validate the procedure for determination of related impurities in the new substance of 7-(4-fluoro-benzyl)-3-tioxo-2,3-dihydro[1,2,4]triazolo[4,3-а]pyrazin-8(7н)-one by the method of high-performance liquid chromatography (HPLC).
Methods. HPLC method has been chosen among other methods since this high sensitive and selective analytical method allows monitoring related impurities in the given substance.
Results. The method for determination of related impurities in the new substance of 7-(4-fluoro-benzyl)-3-tioxo-2,3-dihydro[1,2,4]triazolo[4,3-а]pyrazin-8(7н)-one has been developed. Validation characteristics have been determined, and their compliance with the relevant eligibility criteria has been experimentally verified.
Conclusion. The results of research show that the developed method meets the modern requirements for analytical methods of the content of impurities limit determination and allows clearly characterize the content of impurities in the new API
References
Ajani, O. O., Nwinyi, O. C. (2009). Synthesis and evaluation of antimicrobial activity of phenyl- and furan-2-yl[1,2,4]triazolo[4,3-a]quinoxalin-4(5H)-one and their hydrazone precursors. Canadian Journal of Pure & Applied Sciences, 3 (3), 983–992. Available at: http://eprints.covenantuniversity.edu.ng/98/1/Ajani-Nwinyi_CJPAS.pdf
Labroli, M., Czarniecki, M. F., Poker, C. S. (2011). Pat. US 2013/0196986 A1 Triazolopyrazinones as P2X7 receptor antagonists. № EP2619204 A4; st. 16.09.2011; app. 29.09.2014.
Taher, А., Khalil, N. A., Ahmed, E. M. (2009). Synthesis of certain 1,2,4-triazolo[4,3-a]quinoxalinone derivatives for evaluation of in vitro antitumor and antimicrobial activities. Bulletin of the Faculty of Pharmacy (Cairo University), 1 (47), 19–26.
Krishnan, V. S. H. et. al (1994). Reaction of 3-hydrazinoquinoxalin-2(1H)-one with aromatic/heteroaromatic carboxylic acids using diphenylphosphoryl azide: synthesis and antiallergic activity of s-triazolo[4,3-a]quinoxalin-4-ones. Indian Journal of Heterocyclic Chemistry, 3 (4), 227–232.
Timofeevski, S. L., McTigue, M. A., Ryan, K., Cui, J., Zou, H. Y., Zhu, J. X. et. al (2009). Enzymatic Characterization of c-Met Receptor Tyrosine Kinase Oncogenic Mutants and Kinetic Studies with Aminopyridine and Triazolopyrazine Inhibitors. Biochemistry, 48 (23), 5339–5349. doi: 10.1021/bi900438w
Derzhavna Farmakopeja Ukrai'ny. Vol. 1 (2015). Kharkiv: DP «Ukrai'ns'kyj naukovyj farmakopejnyj centr jakosti likars'kyh zasobiv», 1130.
Solovova, N. V., Kurbatova, S. V., Belousova, Z. P., Osokin, D. M. (2002). Zhidkostnaja hromatografija nekotoryh proizvodnyh pjatichlennyh geterociklov. Vestnik SamGU – Estestvennonauchnaja serija, 4 (26), 113–119.
Komissarova, N. V., Bulanova, A. V., Purygin, P. P. et. al (2008). Izuchenie hromatograficheskogo povedenija nekotoryh azolov v uslovijah vysokojeffektivnoj zhidkostnoj hromatografii. Sorbcionnye i hromatograficheskie processy, 8 (6), 964–970. Available at: http://www.sorpchrom.vsu.ru/articles/20080611.pdf
Poljakova, Ju. L., Bulanova, A. V., Egorova, K. V. et. al (2000). Svjaz' jenergeticheskih harakteristik i indeksa Randicha imidazola i nekotoryh azolidov sul'fokislot s hromatograficheskim uderzhivaniem. Izvestija RAN. Ser. Him, 8, 1401–1404.
Gryzodub, O. I., Leont'jev, D. A., Docenko, T. M. et. al (2004). Standartyzovana procedura validacii' metodyk kil'kisnogo vyznachennja likars'kyh zasobiv metodom standartu. Farmakom, 3, 3–17.
Downloads
Published
Issue
Section
License
Copyright (c) 2016 Кристина Юрьевна Нетёсова, Светлана Николаевна Губарь, Ирина Александровна Журавель
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.
Authors, who are published in this journal, agree to the following conditions:
1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons CC BY, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.
2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.
