CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE

An accelerated chemical stability study of Prednisone oral suspension has been performed during 6 months. A stability indicating chromatographic method was developed and validated according to the ICH guidelines by reversed phase using a Chromolith® C-18e monolithic column 4.6 x 100 mm, water:tetrah...

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Autores principales:	MÜLLER,CLAUDIO, GODOY,GLORIA, DE DIEGO,MARTA
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2011
Materias:	Accelerated Chemical Stability Prednisone Oral Suspension Liquid Chromatography
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000300005
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spelling	oai:scielo:S0717-970720110003000052012-01-11CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCEMÜLLER,CLAUDIOGODOY,GLORIADE DIEGO,MARTA Accelerated Chemical Stability Prednisone Oral Suspension Liquid Chromatography An accelerated chemical stability study of Prednisone oral suspension has been performed during 6 months. A stability indicating chromatographic method was developed and validated according to the ICH guidelines by reversed phase using a Chromolith® C-18e monolithic column 4.6 x 100 mm, water:tetrahydrofuran:methanol 73:23:4 v/v/v as mobile phase, UV detection at 243 nm and 1 mL/min flow rate. Prednisolone was used as internal standard. Prednisone drug substance was subjected to forced degradation by acid and basic hydrolysis and oxidation condition, UV-Vis radiation effect, temperature and relative humidity were studied to demonstrate the indicating capability of the chromatographic method. Two and five degradation products were detected at acid and basic forced degradation respectively. No degradation products were detected at the others studied conditions. One degradation product from Prednisone oral suspension was detected during the accelerated chemical stability study. The proposed method was adequate to determine Prednisone drug substance, Prednisone oral suspension and their degradation products. The kinetic parameters of Prednisone oral suspension under the studied conditions are also reported.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.56 n.3 20112011-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000300005en10.4067/S0717-97072011000300005
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Accelerated Chemical Stability Prednisone Oral Suspension Liquid Chromatography
spellingShingle	Accelerated Chemical Stability Prednisone Oral Suspension Liquid Chromatography MÜLLER,CLAUDIO GODOY,GLORIA DE DIEGO,MARTA CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE
description	An accelerated chemical stability study of Prednisone oral suspension has been performed during 6 months. A stability indicating chromatographic method was developed and validated according to the ICH guidelines by reversed phase using a Chromolith® C-18e monolithic column 4.6 x 100 mm, water:tetrahydrofuran:methanol 73:23:4 v/v/v as mobile phase, UV detection at 243 nm and 1 mL/min flow rate. Prednisolone was used as internal standard. Prednisone drug substance was subjected to forced degradation by acid and basic hydrolysis and oxidation condition, UV-Vis radiation effect, temperature and relative humidity were studied to demonstrate the indicating capability of the chromatographic method. Two and five degradation products were detected at acid and basic forced degradation respectively. No degradation products were detected at the others studied conditions. One degradation product from Prednisone oral suspension was detected during the accelerated chemical stability study. The proposed method was adequate to determine Prednisone drug substance, Prednisone oral suspension and their degradation products. The kinetic parameters of Prednisone oral suspension under the studied conditions are also reported.
author	MÜLLER,CLAUDIO GODOY,GLORIA DE DIEGO,MARTA
author_facet	MÜLLER,CLAUDIO GODOY,GLORIA DE DIEGO,MARTA
author_sort	MÜLLER,CLAUDIO
title	CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE
title_short	CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE
title_full	CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE
title_fullStr	CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE
title_full_unstemmed	CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE
title_sort	chemical stability of prednisone oral suspension and drug substance
publisher	Sociedad Chilena de Química
publishDate	2011
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000300005
work_keys_str_mv	AT mullerclaudio chemicalstabilityofprednisoneoralsuspensionanddrugsubstance AT godoygloria chemicalstabilityofprednisoneoralsuspensionanddrugsubstance AT dediegomarta chemicalstabilityofprednisoneoralsuspensionanddrugsubstance
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CHEMICAL STABILITY OF PREDNISONE ORAL SUSPENSION AND DRUG SUBSTANCE

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