Drug Testing and Analysis
Strategy for identification and characterization of small quantities of drug degradation products using LC and LC-MS: Application to valsartan, a model drug
1
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar 160 062, Punjab, India
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Publication type: Journal Article
Publication date: 2010-02-09
Journal:
Drug Testing and Analysis
Quartile SCImago
Q1
Quartile WOS
Q2
Impact factor: 2.9
ISSN: 19427603, 19427611
DOI:
10.1002/dta.116
Spectroscopy
Pharmaceutical Science
Analytical Chemistry
Environmental Chemistry
Abstract
The present study demonstrates the applicability of a strategy involving use of liquid chromatography (LC) and liquid chromatography-mass spectrometry (LC-MS) techniques for the identification and characterization of minute quantities of degradation products, without their isolation from the reaction matrix in pure form. Valsartan was used as a model drug. It was subjected to forced degradation studies under the International Conference on Harmonisation (ICH) prescribed conditions of hydrolysis (acid, base and neutral), photolysis, oxidation and thermal stress. The drug showed labiality under acid/neutral hydrolytic and photolytic conditions, while it was stable to base hydrolytic, oxidative and thermal stress. Three small degradation products were formed, which were separated on a C-18 column using a gradient method. The same were characterized with the help of their fragmentation pattern and accurate masses obtained upon LC-MS/TOF analyses and online H/D exchange studies. The structures were supported by appropriate mechanistic explanation. The strategy involving use of LC and LC-MS for the identification and characterization of minute quantities of degradation products was applied on a model drug, valsartan. Three degradation products were successfully characterised without their isolation from the reaction matrix in pure form. The structures were supported by appropriate mechanistic explanation. Copyright © 2010 John Wiley & Sons, Ltd.
Top-30
Citations by journals
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Chemical Research in Toxicology
1 publication, 20%
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Journal of Chromatography A
1 publication, 20%
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Analytical Chemistry
1 publication, 20%
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Russian Chemical Reviews
1 publication, 20%
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1
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Citations by publishers
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1
2
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American Chemical Society (ACS)
2 publications, 40%
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Elsevier
1 publication, 20%
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Wiley
1 publication, 20%
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Autonomous Non-profit Organization Editorial Board of the journal Uspekhi Khimii
1 publication, 20%
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2
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- We do not take into account publications without a DOI.
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- Statistics recalculated weekly.
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Mehta S., Shah R. P., Singh S. Strategy for identification and characterization of small quantities of drug degradation products using LC and LC-MS: Application to valsartan, a model drug // Drug Testing and Analysis. 2010.
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Mehta S., Shah R. P., Singh S. Strategy for identification and characterization of small quantities of drug degradation products using LC and LC-MS: Application to valsartan, a model drug // Drug Testing and Analysis. 2010.
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TY - JOUR
DO - 10.1002/dta.116
UR - https://doi.org/10.1002/dta.116
TI - Strategy for identification and characterization of small quantities of drug degradation products using LC and LC-MS: Application to valsartan, a model drug
T2 - Drug Testing and Analysis
AU - Mehta, Surbhi
AU - Shah, Ravi P
AU - Singh, Saranjit
PY - 2010
DA - 2010/02/09 00:00:00
PB - Wiley
SN - 1942-7603
SN - 1942-7611
ER -
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@article{2010_Mehta,
author = {Surbhi Mehta and Ravi P Shah and Saranjit Singh},
title = {Strategy for identification and characterization of small quantities of drug degradation products using LC and LC-MS: Application to valsartan, a model drug},
journal = {Drug Testing and Analysis},
year = {2010},
publisher = {Wiley},
month = {feb},
url = {https://doi.org/10.1002/dta.116},
doi = {10.1002/dta.116}
}