STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD

Ramipril is an angiotensin-converting enzyme inhibitor which has chemical structure susceptible to degradation, therefore in this work forced degradation studies of ramipril were carried out by a developed and validated stability-indicating liquid chromatographic method. Stress testing was performed...

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Autores principales:	DE DIEGO,M, GODOY,G, MENNICKENT,S, OLIVARES,M, GODOY,R
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2010
Materias:	Stress testing stability-indicating ramipril drug substance tablets
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000400008
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spelling	oai:scielo:S0717-970720100004000082011-05-25STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHODDE DIEGO,MGODOY,GMENNICKENT,SOLIVARES,MGODOY,R Stress testing stability-indicating ramipril drug substance tablets Ramipril is an angiotensin-converting enzyme inhibitor which has chemical structure susceptible to degradation, therefore in this work forced degradation studies of ramipril were carried out by a developed and validated stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under hydrolysis (0.1 N HCl, water and 0.1 N NaOH), oxidation (3% H2O2), heat (70°C) and photolysis (UV and VIS radiation). The drug was degraded under acidic, neutral, alkaline, oxidation and thermal stress conditions but it was stable under photolysis. Chromatographic separation of ramipril from its degradation products was achieved on a RP-18 column, using a mobile phase consisting of methanol - tetrahydrofuran - phosphate buffer (pH 2.4; 0.01M) (55:5:40, v/v/v) at a flow rate of 1.0 mL min-1 and UV detection at 215 nm. The assay was linear for ramipril concentrations of 50-300 ug/mL. The developed method was stability indicating, specific, accurate and precise for ramipril determination. This method was used to quantify ramipril in tablets. The results showed that the method described here is suitable for quantitative determination and the stability study of ramipril.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.55 n.4 20102010-12-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000400008en10.4067/S0717-97072010000400008
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Stress testing stability-indicating ramipril drug substance tablets
spellingShingle	Stress testing stability-indicating ramipril drug substance tablets DE DIEGO,M GODOY,G MENNICKENT,S OLIVARES,M GODOY,R STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
description	Ramipril is an angiotensin-converting enzyme inhibitor which has chemical structure susceptible to degradation, therefore in this work forced degradation studies of ramipril were carried out by a developed and validated stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under hydrolysis (0.1 N HCl, water and 0.1 N NaOH), oxidation (3% H2O2), heat (70°C) and photolysis (UV and VIS radiation). The drug was degraded under acidic, neutral, alkaline, oxidation and thermal stress conditions but it was stable under photolysis. Chromatographic separation of ramipril from its degradation products was achieved on a RP-18 column, using a mobile phase consisting of methanol - tetrahydrofuran - phosphate buffer (pH 2.4; 0.01M) (55:5:40, v/v/v) at a flow rate of 1.0 mL min-1 and UV detection at 215 nm. The assay was linear for ramipril concentrations of 50-300 ug/mL. The developed method was stability indicating, specific, accurate and precise for ramipril determination. This method was used to quantify ramipril in tablets. The results showed that the method described here is suitable for quantitative determination and the stability study of ramipril.
author	DE DIEGO,M GODOY,G MENNICKENT,S OLIVARES,M GODOY,R
author_facet	DE DIEGO,M GODOY,G MENNICKENT,S OLIVARES,M GODOY,R
author_sort	DE DIEGO,M
title	STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_short	STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_full	STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_fullStr	STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_full_unstemmed	STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
title_sort	stress degradation studies of ramipril by a validated stability-indicating liquid chromatographic method
publisher	Sociedad Chilena de Química
publishDate	2010
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000400008
work_keys_str_mv	AT dediegom stressdegradationstudiesoframiprilbyavalidatedstabilityindicatingliquidchromatographicmethod AT godoyg stressdegradationstudiesoframiprilbyavalidatedstabilityindicatingliquidchromatographicmethod AT mennickents stressdegradationstudiesoframiprilbyavalidatedstabilityindicatingliquidchromatographicmethod AT olivaresm stressdegradationstudiesoframiprilbyavalidatedstabilityindicatingliquidchromatographicmethod AT godoyr stressdegradationstudiesoframiprilbyavalidatedstabilityindicatingliquidchromatographicmethod
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STRESS DEGRADATION STUDIES OF RAMIPRIL BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD

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