Detection and structure elucidation of the new degradation impurities in the pharmaceutical formulations of ruxolitinib hydrobromide
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F20%3A43923834" target="_blank" >RIV/60461373:22340/20:43923834 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S0731708520303265?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0731708520303265?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jpba.2020.113266" target="_blank" >10.1016/j.jpba.2020.113266</a>
Alternative languages
Result language
angličtina
Original language name
Detection and structure elucidation of the new degradation impurities in the pharmaceutical formulations of ruxolitinib hydrobromide
Original language description
New degradation impurities at m/z 327.15 and m/z 311.16 using gradient UHPLC method with UV detection and highly selective QDa mass detection were observed during the ruxolitinib hydrobromide (RUX.HBr) : excipient binary mixture degradation study. High mass resolution LC–MS and nuclear magnetic resonance (NMR) techniques were employed to identify and fully characterize the degradation compounds. The degradation impurities were unambiguously identified as (R)-4-amino-6-(1-(2-cyano-1-cyclopentylethyl)-1H-pyrazol-4-yl)pyrimidine-5-carboxylic acid and (R)-3-(4-(6-amino-5-formylpyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile and mechanism of their formation was proposed. It has been confirmed that the degradation products are formed in mixtures of RUX.HBr with some excipients in the presence of oxygen. Based on the forced degradation study, the chemically stable of pharmaceutical formulations were prepared to eliminate the formation of these impurities. © 2020 Elsevier B.V.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10406 - Analytical chemistry
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2020
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Pharmaceutical and Biomedical Analysis
ISSN
0731-7085
e-ISSN
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Volume of the periodical
186
Issue of the periodical within the volume
JUL 15 2020
Country of publishing house
GB - UNITED KINGDOM
Number of pages
6
Pages from-to
113266
UT code for WoS article
000541133300051
EID of the result in the Scopus database
2-s2.0-85083644306