A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS

In this study, a new, simple and specific stability indicating ion-pair LC method was developed and fully validated for the determination of asenapine in tablets. The analysis was performed on an Agilent Eclipse XDB-C8 column (4.6 x 150 mm, 3.5 μm particles) at 30°C. A mixture of phosphate...

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Autores principales:	KARACA,SAKINE ATILA, UGUR,DUYGU YENICELI
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2017
Materias:	asenapine HPLC ion-pair chromatography tablet analysis
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000100004
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spelling	oai:scielo:S0717-970720170001000042017-05-05A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALSKARACA,SAKINE ATILAUGUR,DUYGU YENICELI asenapine HPLC ion-pair chromatography tablet analysis In this study, a new, simple and specific stability indicating ion-pair LC method was developed and fully validated for the determination of asenapine in tablets. The analysis was performed on an Agilent Eclipse XDB-C8 column (4.6 x 150 mm, 3.5 μm particles) at 30°C. A mixture of phosphate buffer (pH 3, 20 mM) containing 10 mM 1-heptane sulfonic acid and acetonitrile, (60:40, v/v) at a flow rate of 1 mL min-1 was used as mobile phase. Detection was performed by a diode array detector at 220 nm. The developed method was validated according to related ICH guideline and US Pharmacopeia and it was suitable in terms of accuracy, precision, specificity, robustness and stability. The method was linear in the concentration range of 0.5-100 μg mL-1. Limit of detection and limit of quantification values were calculated as 0.0836 μg mL-1 and 0.2788 μg mL-1, respectively. This ion-pair LC method was applied successfully for the determination of asenapine in its sublingual tablets.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.62 n.1 20172017-03-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000100004en10.4067/S0717-97072017000100004
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	asenapine HPLC ion-pair chromatography tablet analysis
spellingShingle	asenapine HPLC ion-pair chromatography tablet analysis KARACA,SAKINE ATILA UGUR,DUYGU YENICELI A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS
description	In this study, a new, simple and specific stability indicating ion-pair LC method was developed and fully validated for the determination of asenapine in tablets. The analysis was performed on an Agilent Eclipse XDB-C8 column (4.6 x 150 mm, 3.5 μm particles) at 30°C. A mixture of phosphate buffer (pH 3, 20 mM) containing 10 mM 1-heptane sulfonic acid and acetonitrile, (60:40, v/v) at a flow rate of 1 mL min-1 was used as mobile phase. Detection was performed by a diode array detector at 220 nm. The developed method was validated according to related ICH guideline and US Pharmacopeia and it was suitable in terms of accuracy, precision, specificity, robustness and stability. The method was linear in the concentration range of 0.5-100 μg mL-1. Limit of detection and limit of quantification values were calculated as 0.0836 μg mL-1 and 0.2788 μg mL-1, respectively. This ion-pair LC method was applied successfully for the determination of asenapine in its sublingual tablets.
author	KARACA,SAKINE ATILA UGUR,DUYGU YENICELI
author_facet	KARACA,SAKINE ATILA UGUR,DUYGU YENICELI
author_sort	KARACA,SAKINE ATILA
title	A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS
title_short	A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS
title_full	A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS
title_fullStr	A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS
title_full_unstemmed	A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS
title_sort	stability indicating ion-pair lc method for the determination of asenapine in pharmaceuticals
publisher	Sociedad Chilena de Química
publishDate	2017
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000100004
work_keys_str_mv	AT karacasakineatila astabilityindicatingionpairlcmethodforthedeterminationofasenapineinpharmaceuticals AT ugurduyguyeniceli astabilityindicatingionpairlcmethodforthedeterminationofasenapineinpharmaceuticals AT karacasakineatila stabilityindicatingionpairlcmethodforthedeterminationofasenapineinpharmaceuticals AT ugurduyguyeniceli stabilityindicatingionpairlcmethodforthedeterminationofasenapineinpharmaceuticals
_version_	1714200905518153728

A STABILITY INDICATING ION-PAIR LC METHOD FOR THE DETERMINATION OF ASENAPINE IN PHARMACEUTICALS

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