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Monitoring of bisoprolol fumarate stability under different stress conditions

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Authors
Kasagić-Vujanović, Irena
Jančić-Stojanović, Biljana
Ivanović, Darko
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Abstract
Stability studies of drugs by stress study is a very important process which is done by treating the study drug with different stress agents, with the aim to define the critical factors affecting the stability of the drug, to accurately define the storage conditions of the drug, as well as to identify the resulting degradation products. In this paper, stress studies of bisoprolol fumarate were performed, in order to examine what are the stress agents that affect its stability. For the analysis previously optimized and validated HILIC method was used It was demonstrated that oxidative stress agent has the largest effect on the degradation of bisoprolol fumarate, and then the acid and base stress agent successively. Water, as a neutral medium, and light had no significant effect on the stability of bisoprolol fumarate. During degradation under acid conditions impurity A was formed and it was confirmed with UPLC/MS/MS method. In order to more clearly define the processes of degradation, k...inetic studies of degradation of bisoprolol fumarate have been carried out, in order to determine the order of the reaction rate of degradation and degradation half-time, which provided clearer definition of the mechanism of degradation.

Source:
Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017, 2017, 62, 415-424
Publisher:
  • Springer-Verlag Singapore Pte Ltd, Singapore

DOI: 10.1007/978-981-10-4166-2_64

ISSN: 1680-0737

WoS: 000462537100064

Scopus: 2-s2.0-85016001937
[ Google Scholar ]
8
2
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2962
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - CONF
AU  - Kasagić-Vujanović, Irena
AU  - Jančić-Stojanović, Biljana
AU  - Ivanović, Darko
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2962
AB  - Stability studies of drugs by stress study is a very important process which is done by treating the study drug with different stress agents, with the aim to define the critical factors affecting the stability of the drug, to accurately define the storage conditions of the drug, as well as to identify the resulting degradation products. In this paper, stress studies of bisoprolol fumarate were performed, in order to examine what are the stress agents that affect its stability. For the analysis previously optimized and validated HILIC method was used It was demonstrated that oxidative stress agent has the largest effect on the degradation of bisoprolol fumarate, and then the acid and base stress agent successively. Water, as a neutral medium, and light had no significant effect on the stability of bisoprolol fumarate. During degradation under acid conditions impurity A was formed and it was confirmed with UPLC/MS/MS method. In order to more clearly define the processes of degradation, kinetic studies of degradation of bisoprolol fumarate have been carried out, in order to determine the order of the reaction rate of degradation and degradation half-time, which provided clearer definition of the mechanism of degradation.
PB  - Springer-Verlag Singapore Pte Ltd, Singapore
C3  - Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017
T1  - Monitoring of bisoprolol fumarate stability under different stress conditions
VL  - 62
SP  - 415
EP  - 424
DO  - 10.1007/978-981-10-4166-2_64
ER  - 
@conference{
author = "Kasagić-Vujanović, Irena and Jančić-Stojanović, Biljana and Ivanović, Darko",
year = "2017",
abstract = "Stability studies of drugs by stress study is a very important process which is done by treating the study drug with different stress agents, with the aim to define the critical factors affecting the stability of the drug, to accurately define the storage conditions of the drug, as well as to identify the resulting degradation products. In this paper, stress studies of bisoprolol fumarate were performed, in order to examine what are the stress agents that affect its stability. For the analysis previously optimized and validated HILIC method was used It was demonstrated that oxidative stress agent has the largest effect on the degradation of bisoprolol fumarate, and then the acid and base stress agent successively. Water, as a neutral medium, and light had no significant effect on the stability of bisoprolol fumarate. During degradation under acid conditions impurity A was formed and it was confirmed with UPLC/MS/MS method. In order to more clearly define the processes of degradation, kinetic studies of degradation of bisoprolol fumarate have been carried out, in order to determine the order of the reaction rate of degradation and degradation half-time, which provided clearer definition of the mechanism of degradation.",
publisher = "Springer-Verlag Singapore Pte Ltd, Singapore",
journal = "Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017",
title = "Monitoring of bisoprolol fumarate stability under different stress conditions",
volume = "62",
pages = "415-424",
doi = "10.1007/978-981-10-4166-2_64"
}
Kasagić-Vujanović, I., Jančić-Stojanović, B.,& Ivanović, D.. (2017). Monitoring of bisoprolol fumarate stability under different stress conditions. in Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017
Springer-Verlag Singapore Pte Ltd, Singapore., 62, 415-424.
https://doi.org/10.1007/978-981-10-4166-2_64
Kasagić-Vujanović I, Jančić-Stojanović B, Ivanović D. Monitoring of bisoprolol fumarate stability under different stress conditions. in Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017. 2017;62:415-424.
doi:10.1007/978-981-10-4166-2_64 .
Kasagić-Vujanović, Irena, Jančić-Stojanović, Biljana, Ivanović, Darko, "Monitoring of bisoprolol fumarate stability under different stress conditions" in Proceedings of the International Conference on Medical and Biological Engineering 2017 (Cmbebih 2017, 62 (2017):415-424,
https://doi.org/10.1007/978-981-10-4166-2_64 . .

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