Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation

Ivabradine is a modern drug that selectively lowers the heart rate, improves cardiac energy balance, and reduces heart’s demands for oxygen and energy. Due to the chemical nature of ivabradine, which absorbs light at 207 nm and 286 nm, its detection was performed at two wavelengths. A Knauer C8 colu...

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Main Authors: Joanna Nowakowska, Piotr Pikul, Marcin Marszałł, Krzesimir Ciura
Format: Article
Language:English
Published: Wiley 2017-01-01
Series:Journal of Chemistry
Online Access:http://dx.doi.org/10.1155/2017/2069571
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author Joanna Nowakowska
Piotr Pikul
Marcin Marszałł
Krzesimir Ciura
author_facet Joanna Nowakowska
Piotr Pikul
Marcin Marszałł
Krzesimir Ciura
author_sort Joanna Nowakowska
collection DOAJ
description Ivabradine is a modern drug that selectively lowers the heart rate, improves cardiac energy balance, and reduces heart’s demands for oxygen and energy. Due to the chemical nature of ivabradine, which absorbs light at 207 nm and 286 nm, its detection was performed at two wavelengths. A Knauer C8 column was used to develop the RP-HPLC method for determination of ivabradine. The proposed method was linear from 5 to 100 µg/ml (r>0.999) for both wavelengths and limits of detection (LOD) and limits of quantification (LOQ) were 0.33 and 1.09 µg/ml for 207 nm and 1.19 and 3.97 µg/ml for 286 nm, respectively. After validation, the investigated method was applied to a stress degradation study. Numerous degradation products were formed from ivabradine solutions through alkaline and acid hydrolysis, oxidation, and photolysis. The largest numbers of degradation products were found in the sample exposed to 24 h radiation and alkaline hydrolysis (eight and six products, resp.). Finally, the simple method using HPLC-UV-DAD was developed and validated. Its usefulness for the monitoring of possible degradation products was demonstrated.
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institution Kabale University
issn 2090-9063
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spelling doaj-art-e58666e3bbe04c82b5b17e0ba06801a62025-02-03T05:59:32ZengWileyJournal of Chemistry2090-90632090-90712017-01-01201710.1155/2017/20695712069571Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress DegradationJoanna Nowakowska0Piotr Pikul1Marcin Marszałł2Krzesimir Ciura3Department of Physical Chemistry, Medical University of Gdańsk, Gdańsk, PolandDepartment of Physical Chemistry, Medical University of Gdańsk, Gdańsk, PolandDepartment of Toxicology, Medical University of Gdańsk, Gdańsk, PolandDepartment of Physical Chemistry, Medical University of Gdańsk, Gdańsk, PolandIvabradine is a modern drug that selectively lowers the heart rate, improves cardiac energy balance, and reduces heart’s demands for oxygen and energy. Due to the chemical nature of ivabradine, which absorbs light at 207 nm and 286 nm, its detection was performed at two wavelengths. A Knauer C8 column was used to develop the RP-HPLC method for determination of ivabradine. The proposed method was linear from 5 to 100 µg/ml (r>0.999) for both wavelengths and limits of detection (LOD) and limits of quantification (LOQ) were 0.33 and 1.09 µg/ml for 207 nm and 1.19 and 3.97 µg/ml for 286 nm, respectively. After validation, the investigated method was applied to a stress degradation study. Numerous degradation products were formed from ivabradine solutions through alkaline and acid hydrolysis, oxidation, and photolysis. The largest numbers of degradation products were found in the sample exposed to 24 h radiation and alkaline hydrolysis (eight and six products, resp.). Finally, the simple method using HPLC-UV-DAD was developed and validated. Its usefulness for the monitoring of possible degradation products was demonstrated.http://dx.doi.org/10.1155/2017/2069571
spellingShingle Joanna Nowakowska
Piotr Pikul
Marcin Marszałł
Krzesimir Ciura
Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
Journal of Chemistry
title Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
title_full Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
title_fullStr Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
title_full_unstemmed Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
title_short Application and Validation of Simple Isocratic HPLC-UV-DAD Method with Dual Wavelength Detection for Ivabradine Determination and Its Application in the Study of Stress Degradation
title_sort application and validation of simple isocratic hplc uv dad method with dual wavelength detection for ivabradine determination and its application in the study of stress degradation
url http://dx.doi.org/10.1155/2017/2069571
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AT marcinmarszałł applicationandvalidationofsimpleisocratichplcuvdadmethodwithdualwavelengthdetectionforivabradinedeterminationanditsapplicationinthestudyofstressdegradation
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