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Study of forced degradation of amlodipine besylate and bisoprolol fumarate by application of hydrophilic interaction liquid chromatography

Studije forsirane degradacije amlodipin-besilata i bisoprolol-fumarata primjenom tečne hromatografije hidrofilnih interakcija

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2014
2280.pdf (405.6Kb)
Authors
Kasagić-Vujanović, Irena
Jančić-Stojanović, Biljana
Ivanović, Darko
Article (Published version)
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Abstract
Currently, in pharmaceutical analysis, great importance is given to forced degradation studies, which can greatly help to predict the shelf life of the drug, but also for identification of possible degradation products. These studies enable investigation of stability indicating method, then it is used to test the active substances intrinsic/inner molecular stability, as well as defining active substances impurity profiles. In this work forced degradation studies of amlodipine besylate and bisoprolol fumarate either individually and in mixtures, was performed, where the method of hydrophilic interaction liquid chromatography was used, and any possible changes in the concentration of samples were followed. The results showed that the test compounds are sensitive to the tested stress agents, especially amlodipine besylate, and that both of these compounds showed increased stability in the mixture in comparison to individual analysis.
U savremenim farmaceutskim analizama danas se veliki značaj pridaje studijama forsirane degradacije, koje mogu u velikoj mjeri pomoći u predviđanju roka upotrebe lijeka, ali i u identifikaciji mogućih proizvoda degradacije. Ove studije omogućavaju ispitivanje specifičnosti stability indicating metode, zatim koriste se za ispitivanje intrinzičke/unutrašnje stabilnosti molekule aktivnih supstanci, kao i za definisanje profila nečistoća aktivnih supstanci. U ovom radu vršena je studija forsirane degradacije amlodipin-besilata i bisoprolol-fumarata pojedinačno i u smješi, gdje se kao metoda koristila tečna hromatografija hidrofilnih interakcija, kojom su se pratile promjene koncentracije ispitivanih uzoraka. Rezultati ispitivanja pokazali su da su ispitivana jedinjenja osjetljiva na većinu ispitivanih stres agenasa, naročito amlodipinbesilat, kao i da su oba ova jedinjenja pokazala veću stabilnost u smješi, nego kad su pojedinačno analizirana.
Keywords:
amlodipine besylate / bisoprolol fumarate / forced degradation study / hydrophilic interaction liquid chromatography / amlodipin-besilat / bisoprolol-fumarat / studije forsirane degradacije / hromatografija hidrofilnih interakcija
Source:
Arhiv za farmaciju, 2014, 64, 3, 230-246
Publisher:
  • Savez farmaceutskih udruženja Srbije, Beograd
Funding / projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.5937/arhfarm1403230K

ISSN: 0004-1963

Scopus: 2-s2.0-84943796921
[ Google Scholar ]
3
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2282
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Kasagić-Vujanović, Irena
AU  - Jančić-Stojanović, Biljana
AU  - Ivanović, Darko
PY  - 2014
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2282
AB  - Currently, in pharmaceutical analysis, great importance is given to forced degradation studies, which can greatly help to predict the shelf life of the drug, but also for identification of possible degradation products. These studies enable investigation of stability indicating method, then it is used to test the active substances intrinsic/inner molecular stability, as well as defining active substances impurity profiles. In this work forced degradation studies of amlodipine besylate and bisoprolol fumarate either individually and in mixtures, was performed, where the method of hydrophilic interaction liquid chromatography was used, and any possible changes in the concentration of samples were followed. The results showed that the test compounds are sensitive to the tested stress agents, especially amlodipine besylate, and that both of these compounds showed increased stability in the mixture in comparison to individual analysis.
AB  - U savremenim farmaceutskim analizama danas se veliki značaj pridaje studijama forsirane degradacije, koje mogu u velikoj mjeri pomoći u predviđanju roka upotrebe lijeka, ali i u identifikaciji mogućih proizvoda degradacije. Ove studije omogućavaju ispitivanje specifičnosti stability indicating metode, zatim koriste se za ispitivanje intrinzičke/unutrašnje stabilnosti molekule aktivnih supstanci, kao i za definisanje profila nečistoća aktivnih supstanci. U ovom radu vršena je studija forsirane degradacije amlodipin-besilata i bisoprolol-fumarata pojedinačno i u smješi, gdje se kao metoda koristila tečna hromatografija hidrofilnih interakcija, kojom su se pratile promjene koncentracije ispitivanih uzoraka. Rezultati ispitivanja pokazali su da su ispitivana jedinjenja osjetljiva na većinu ispitivanih stres agenasa, naročito amlodipinbesilat, kao i da su oba ova jedinjenja pokazala veću stabilnost u smješi, nego kad su pojedinačno analizirana.
PB  - Savez farmaceutskih udruženja Srbije, Beograd
T2  - Arhiv za farmaciju
T1  - Study of forced degradation of amlodipine besylate and bisoprolol fumarate by application of hydrophilic interaction liquid chromatography
T1  - Studije forsirane degradacije amlodipin-besilata i bisoprolol-fumarata primjenom tečne hromatografije hidrofilnih interakcija
VL  - 64
IS  - 3
SP  - 230
EP  - 246
DO  - 10.5937/arhfarm1403230K
ER  - 
@article{
author = "Kasagić-Vujanović, Irena and Jančić-Stojanović, Biljana and Ivanović, Darko",
year = "2014",
abstract = "Currently, in pharmaceutical analysis, great importance is given to forced degradation studies, which can greatly help to predict the shelf life of the drug, but also for identification of possible degradation products. These studies enable investigation of stability indicating method, then it is used to test the active substances intrinsic/inner molecular stability, as well as defining active substances impurity profiles. In this work forced degradation studies of amlodipine besylate and bisoprolol fumarate either individually and in mixtures, was performed, where the method of hydrophilic interaction liquid chromatography was used, and any possible changes in the concentration of samples were followed. The results showed that the test compounds are sensitive to the tested stress agents, especially amlodipine besylate, and that both of these compounds showed increased stability in the mixture in comparison to individual analysis., U savremenim farmaceutskim analizama danas se veliki značaj pridaje studijama forsirane degradacije, koje mogu u velikoj mjeri pomoći u predviđanju roka upotrebe lijeka, ali i u identifikaciji mogućih proizvoda degradacije. Ove studije omogućavaju ispitivanje specifičnosti stability indicating metode, zatim koriste se za ispitivanje intrinzičke/unutrašnje stabilnosti molekule aktivnih supstanci, kao i za definisanje profila nečistoća aktivnih supstanci. U ovom radu vršena je studija forsirane degradacije amlodipin-besilata i bisoprolol-fumarata pojedinačno i u smješi, gdje se kao metoda koristila tečna hromatografija hidrofilnih interakcija, kojom su se pratile promjene koncentracije ispitivanih uzoraka. Rezultati ispitivanja pokazali su da su ispitivana jedinjenja osjetljiva na većinu ispitivanih stres agenasa, naročito amlodipinbesilat, kao i da su oba ova jedinjenja pokazala veću stabilnost u smješi, nego kad su pojedinačno analizirana.",
publisher = "Savez farmaceutskih udruženja Srbije, Beograd",
journal = "Arhiv za farmaciju",
title = "Study of forced degradation of amlodipine besylate and bisoprolol fumarate by application of hydrophilic interaction liquid chromatography, Studije forsirane degradacije amlodipin-besilata i bisoprolol-fumarata primjenom tečne hromatografije hidrofilnih interakcija",
volume = "64",
number = "3",
pages = "230-246",
doi = "10.5937/arhfarm1403230K"
}
Kasagić-Vujanović, I., Jančić-Stojanović, B.,& Ivanović, D.. (2014). Study of forced degradation of amlodipine besylate and bisoprolol fumarate by application of hydrophilic interaction liquid chromatography. in Arhiv za farmaciju
Savez farmaceutskih udruženja Srbije, Beograd., 64(3), 230-246.
https://doi.org/10.5937/arhfarm1403230K
Kasagić-Vujanović I, Jančić-Stojanović B, Ivanović D. Study of forced degradation of amlodipine besylate and bisoprolol fumarate by application of hydrophilic interaction liquid chromatography. in Arhiv za farmaciju. 2014;64(3):230-246.
doi:10.5937/arhfarm1403230K .
Kasagić-Vujanović, Irena, Jančić-Stojanović, Biljana, Ivanović, Darko, "Study of forced degradation of amlodipine besylate and bisoprolol fumarate by application of hydrophilic interaction liquid chromatography" in Arhiv za farmaciju, 64, no. 3 (2014):230-246,
https://doi.org/10.5937/arhfarm1403230K . .

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