Separation and characterization of degradation impurities of upadacitinib by liquid chromatography and high resolution mass spectrometry DOI

Sowmya Chaganti,

Chagnya Nelapati,

Drishti Jain

et al.

Journal of Chromatography B, Journal Year: 2024, Volume and Issue: 1247, P. 124319 - 124319

Published: Sept. 13, 2024

Language: Английский

Separation, characterization and cytotoxicity of unknown forced degradation impurity of selpercatinib using Prep-LC, HRMS and NMR DOI
Qin Wang,

Wenyi Wu,

Rongwei Sun

et al.

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2025, Volume and Issue: 258, P. 116747 - 116747

Published: Feb. 12, 2025

Language: Английский

Citations

0
UPLC-Q-TOF–MS/MS and NMR studies for the structural characterization of degradation impurities of rimegepant DOI

Bhuvaneshwari Vuyyala,

Tarzan Mohanta,

Sai Ram Prasad Kollu

et al.

Analytical and Bioanalytical Chemistry, Journal Year: 2025, Volume and Issue: unknown

Published: March 14, 2025

Language: Английский

Citations

0
Identification and characterization of unknown oxidation degradation products of Rimegepant by HPLC and triple quadrupole mass spectrometry DOI
Narayana Reddy Godi, Sireesha Dodda,

Nagavardhana Reddy Vanga

et al.

European Journal of Mass Spectrometry, Journal Year: 2025, Volume and Issue: unknown

Published: March 26, 2025

Rimegepant is a calcitonin gene-related peptide receptor antagonist that has been licensed for migraine headache treatment in the United States, European Union, Kingdom, Hong Kong, Australia, and Kuwait. The oxidation stress study of drug substance revealed presence five impurities. degraded by 5% under selected conditions, meeting regulatory expectations. Four out impurities are enhanced more than 1%. This research aims to characterize these degradation products utilizing triple quadrupole mass spectroscopic technique. were identified using an optimized chromatographic method relies on reverse-phase HPLC with PDA detection. technique utilized Waters Xbridge C18 column eluent mixture acetonitrile 0.1% formic acid water. have effectively separated, resolution above 3.0. Triple spectrometry analysis characterized products, which showed three N-oxide masses m / z 566, 550, 548, as well two hydrolysis masses, 218, 290. These new deserve special attention because drug's potency related impurity levels determine any pharmaceutical medication product's quality, safety, effectiveness.

Language: Английский

Citations

0
Impurity profiling and stability analysis of enzalutamide: Identification, genotoxicity assessment, and development of UHPLC methods for critical impurities DOI

Burcu Oktar Uzun,

Pelin Kaygu,

Elif Keskin

et al.

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2025, Volume and Issue: unknown, P. 116926 - 116926

Published: April 1, 2025

Language: Английский

Citations

0
Separation and characterization of degradation impurities of upadacitinib by liquid chromatography and high resolution mass spectrometry DOI

Sowmya Chaganti,

Chagnya Nelapati,

Drishti Jain

et al.

Journal of Chromatography B, Journal Year: 2024, Volume and Issue: 1247, P. 124319 - 124319

Published: Sept. 13, 2024

Language: Английский

Citations

0