Forced degradation study of torasemide: Characterization of its degradation products
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Jović, ŽarkoŽivanović, Ljiljana
Protić, Ana

Radisić, Marina
Lausević, Mila
Malešević, Marija
Zečević, Mira

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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 / torasemideSource:
Journal of Liquid Chromatography & Related Technologies, 2013, 36, 15, 2082-2094Publisher:
- Taylor & Francis Inc, Philadelphia
Funding / projects:
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
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PharmacyTY - 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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