STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD

A simple, rapid, and precise method is developed for the quantitative estimation of dronedarone hydrochloride in presence of its degradants which are formed due to stress conditions. A chromatographic separation of the dronedarone and its degradants were achieved with Zorbax XDB C8 150 x 4.6 mm, 3.5...

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Autores principales:	AHIRRAO,V. K, PATIL,C. S, BEMBALKAR,S. R, KATARIYA,M. V, SONNEKAR,V. S, MARATHE,R. P, NAWALE,R. B, PAWAR,R. P
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2012
Materias:	Liquid chromatography Method validation Pharmaceutical preparation Dronedarone hydrochloride and Stress degradation
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300016
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spelling	oai:scielo:S0717-970720120003000162019-02-19STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHODAHIRRAO,V. KPATIL,C. SBEMBALKAR,S. RKATARIYA,M. VSONNEKAR,V. SMARATHE,R. PNAWALE,R. BPAWAR,R. P Liquid chromatography Method validation Pharmaceutical preparation Dronedarone hydrochloride and Stress degradation A simple, rapid, and precise method is developed for the quantitative estimation of dronedarone hydrochloride in presence of its degradants which are formed due to stress conditions. A chromatographic separation of the dronedarone and its degradants were achieved with Zorbax XDB C8 150 x 4.6 mm, 3.5µm analytical column using aqueous solution of 0.05M ammonium acetate and acetonitrile (40:60 v/v). The instrumental settings are flow rate of 1.0 mL/min, column temperature at 30ºC, and detector wavelength of 220 nm using a photodiode array detector. Observed theoretical plates and tailing factor for dronedarone were 6577 and 1.09 respectively. Dronedarone was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of dronedarone is obtained using photodiode array detector. The stressed sample chromatograms demonstrate the specificity of the method for the estimation dronedarone in presence of its degradants. The described method showed excellent linearity over a range of 10 - 300 µg/mL for dronedarone. The correlation coefficient is 0.999. The relative standard deviation of peak area for six measurements is always found to be less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of dronedarone.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.57 n.3 20122012-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300016en10.4067/S0717-97072012000300016
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Liquid chromatography Method validation Pharmaceutical preparation Dronedarone hydrochloride and Stress degradation
spellingShingle	Liquid chromatography Method validation Pharmaceutical preparation Dronedarone hydrochloride and Stress degradation AHIRRAO,V. K PATIL,C. S BEMBALKAR,S. R KATARIYA,M. V SONNEKAR,V. S MARATHE,R. P NAWALE,R. B PAWAR,R. P STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD
description	A simple, rapid, and precise method is developed for the quantitative estimation of dronedarone hydrochloride in presence of its degradants which are formed due to stress conditions. A chromatographic separation of the dronedarone and its degradants were achieved with Zorbax XDB C8 150 x 4.6 mm, 3.5µm analytical column using aqueous solution of 0.05M ammonium acetate and acetonitrile (40:60 v/v). The instrumental settings are flow rate of 1.0 mL/min, column temperature at 30ºC, and detector wavelength of 220 nm using a photodiode array detector. Observed theoretical plates and tailing factor for dronedarone were 6577 and 1.09 respectively. Dronedarone was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of dronedarone is obtained using photodiode array detector. The stressed sample chromatograms demonstrate the specificity of the method for the estimation dronedarone in presence of its degradants. The described method showed excellent linearity over a range of 10 - 300 µg/mL for dronedarone. The correlation coefficient is 0.999. The relative standard deviation of peak area for six measurements is always found to be less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of dronedarone.
author	AHIRRAO,V. K PATIL,C. S BEMBALKAR,S. R KATARIYA,M. V SONNEKAR,V. S MARATHE,R. P NAWALE,R. B PAWAR,R. P
author_facet	AHIRRAO,V. K PATIL,C. S BEMBALKAR,S. R KATARIYA,M. V SONNEKAR,V. S MARATHE,R. P NAWALE,R. B PAWAR,R. P
author_sort	AHIRRAO,V. K
title	STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD
title_short	STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD
title_full	STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD
title_fullStr	STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD
title_full_unstemmed	STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD
title_sort	stress degradation studies of dronedarone in pharmaceutical dosage form by a validated stability-indicating lc method
publisher	Sociedad Chilena de Química
publishDate	2012
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300016
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STRESS DEGRADATION STUDIES OF DRONEDARONE IN PHARMACEUTICAL DOSAGE FORM BY A VALIDATED STABILITY-INDICATING LC METHOD

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