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Forced degradation study of torasemide: Characterization of its degradation products

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Authors
Jović, Žarko
Živanović, Ljiljana
Protić, Ana
Radisić, Marina
Lausević, Mila
Malešević, Marija
Zečević, Mira
Article (Published version)
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Abstract
Torasemide was subjected to forced degradation studies. Stress conditions were varied concerning hydrolysis (acid, base, and neutral), oxidation, photolysis, and thermal degradation in order to identify the potential degradation products and consequently establish the possible degradation pathways and intrinsic stability of the drug. The study was performed according to ICH guidelines and drug was found to be relatively stable in the solid form. It showed that torasemide degraded significantly under acidic, neutral and alkaline conditions and resulted in formation of degradation product R2. When temperature was increased the degradation was accelerated. Also, the drug showed slight instability under extreme oxidative stress conditions which resulted in formation of two degradation products in total. The drug and degradation products have been separated employing gradient elution method on Zorbax SB C-18 analytical column. To characterize the degradation products LC-MSn was applied. The... mass fragmentation pattern was established using single quadrupole and ion trap mass analyzers. Finally, the most possible degradation mechanism of torasemide in different experimental conditions was proposed.

Keywords:
degradation pathway / forced degradation study / HPLC-DAD / HPLC-MS/MS / possible degradation products / torasemide
Source:
Journal of Liquid Chromatography & Related Technologies, 2013, 36, 15, 2082-2094
Publisher:
  • Taylor & Francis Inc, Philadelphia
Funding / projects:
  • Synthesis, Quantitative Structure and Activity Relationship, Physico-Chemical Characterisation and Analysis of Pharmacologically Active Substances (RS-172033)
Note:
  • Peer-reviewed manuscript: http://farfar.pharmacy.bg.ac.rs/handle/123456789/3431

DOI: 10.1080/10826076.2012.712932

ISSN: 1082-6076

WoS: 000320019900003

Scopus: 2-s2.0-84879305860
[ Google Scholar ]
6
5
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1961
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Jović, Žarko
AU  - Živanović, Ljiljana
AU  - Protić, Ana
AU  - Radisić, Marina
AU  - Lausević, Mila
AU  - Malešević, Marija
AU  - Zečević, Mira
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1961
AB  - Torasemide was subjected to forced degradation studies. Stress conditions were varied concerning hydrolysis (acid, base, and neutral), oxidation, photolysis, and thermal degradation in order to identify the potential degradation products and consequently establish the possible degradation pathways and intrinsic stability of the drug. The study was performed according to ICH guidelines and drug was found to be relatively stable in the solid form. It showed that torasemide degraded significantly under acidic, neutral and alkaline conditions and resulted in formation of degradation product R2. When temperature was increased the degradation was accelerated. Also, the drug showed slight instability under extreme oxidative stress conditions which resulted in formation of two degradation products in total. The drug and degradation products have been separated employing gradient elution method on Zorbax SB C-18 analytical column. To characterize the degradation products LC-MSn was applied. The mass fragmentation pattern was established using single quadrupole and ion trap mass analyzers. Finally, the most possible degradation mechanism of torasemide in different experimental conditions was proposed.
PB  - Taylor & Francis Inc, Philadelphia
T2  - Journal of Liquid Chromatography & Related Technologies
T1  - Forced degradation study of torasemide: Characterization of its degradation products
VL  - 36
IS  - 15
SP  - 2082
EP  - 2094
DO  - 10.1080/10826076.2012.712932
ER  - 
@article{
author = "Jović, Žarko and Živanović, Ljiljana and Protić, Ana and Radisić, Marina and Lausević, Mila and Malešević, Marija and Zečević, Mira",
year = "2013",
abstract = "Torasemide was subjected to forced degradation studies. Stress conditions were varied concerning hydrolysis (acid, base, and neutral), oxidation, photolysis, and thermal degradation in order to identify the potential degradation products and consequently establish the possible degradation pathways and intrinsic stability of the drug. The study was performed according to ICH guidelines and drug was found to be relatively stable in the solid form. It showed that torasemide degraded significantly under acidic, neutral and alkaline conditions and resulted in formation of degradation product R2. When temperature was increased the degradation was accelerated. Also, the drug showed slight instability under extreme oxidative stress conditions which resulted in formation of two degradation products in total. The drug and degradation products have been separated employing gradient elution method on Zorbax SB C-18 analytical column. To characterize the degradation products LC-MSn was applied. The mass fragmentation pattern was established using single quadrupole and ion trap mass analyzers. Finally, the most possible degradation mechanism of torasemide in different experimental conditions was proposed.",
publisher = "Taylor & Francis Inc, Philadelphia",
journal = "Journal of Liquid Chromatography & Related Technologies",
title = "Forced degradation study of torasemide: Characterization of its degradation products",
volume = "36",
number = "15",
pages = "2082-2094",
doi = "10.1080/10826076.2012.712932"
}
Jović, Ž., Živanović, L., Protić, A., Radisić, M., Lausević, M., Malešević, M.,& Zečević, M.. (2013). Forced degradation study of torasemide: Characterization of its degradation products. in Journal of Liquid Chromatography & Related Technologies
Taylor & Francis Inc, Philadelphia., 36(15), 2082-2094.
https://doi.org/10.1080/10826076.2012.712932
Jović Ž, Živanović L, Protić A, Radisić M, Lausević M, Malešević M, Zečević M. Forced degradation study of torasemide: Characterization of its degradation products. in Journal of Liquid Chromatography & Related Technologies. 2013;36(15):2082-2094.
doi:10.1080/10826076.2012.712932 .
Jović, Žarko, Živanović, Ljiljana, Protić, Ana, Radisić, Marina, Lausević, Mila, Malešević, Marija, Zečević, Mira, "Forced degradation study of torasemide: Characterization of its degradation products" in Journal of Liquid Chromatography & Related Technologies, 36, no. 15 (2013):2082-2094,
https://doi.org/10.1080/10826076.2012.712932 . .

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