ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS

A reversed phase liquid chromatography (RP-HPLC) and thin layer chromatography (HPTLC) densitometry methods as a stability indicating assays of olmesartan medoxomil in presence of its acid or alkaline induced degradation products were developed. Olmesartan medoxomil and its degradation products were...

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Autores principales:	MOUSSA,BAHIA, MOHAMED,MARWA, YOUSSEF,NADIA
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2010
Materias:	Olmesartan Medoxomil HPLC HPTLC Acid- Alkali Degradation Product Stability-Indicating
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200011
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spelling	oai:scielo:S0717-970720100002000112010-09-06ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODSMOUSSA,BAHIAMOHAMED,MARWAYOUSSEF,NADIA Olmesartan Medoxomil HPLC HPTLC Acid- Alkali Degradation Product Stability-Indicating A reversed phase liquid chromatography (RP-HPLC) and thin layer chromatography (HPTLC) densitometry methods as a stability indicating assays of olmesartan medoxomil in presence of its acid or alkaline induced degradation products were developed. Olmesartan medoxomil and its degradation products were analyzed by HPLC equipped with UV-Variable wave length detector at 257 nm where quantitation was achieved by isocratic elution on Agilent, Exclipse XDB- C column with mobile phase composed of acetonitrile: methanol: water: glacial acetic acid (40:35:25:0.1 v/v/v/v) at flow rate 1 ml min.-1. HPTLC was performed on aluminum packed Nano silica gel 60 F2J4 TLC plates as stationary phase with significant difference in R/ values between olmesartan medoxomil and its degradates using chloroform: methanol: formic acid (8:1.5:0.5 v/v/v) as mobile phase. Densitometric evaluation of intact drug was carried out at 260 nm. The calibration curve of olmesartan medoxomil in bulk form was linear from 0.5- 10 µg ml-1 and 0.05- 1 µg ml-1 with mean percentage accuracy 99.97 ± 1.085 % and 100.35 ± 1.060 % for HPLC and HPTLC methods, respectively. The two proposed methods were successfully applied for the determination of olmesartan medoxomil in drug substance and in drug product. Methods validation was tested for linearity; accuracy; precisión; selectivity and robustness, according to USP guidelines.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.55 n.2 20102010-06-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200011en10.4067/S0717-97072010000200011
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Olmesartan Medoxomil HPLC HPTLC Acid- Alkali Degradation Product Stability-Indicating
spellingShingle	Olmesartan Medoxomil HPLC HPTLC Acid- Alkali Degradation Product Stability-Indicating MOUSSA,BAHIA MOHAMED,MARWA YOUSSEF,NADIA ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS
description	A reversed phase liquid chromatography (RP-HPLC) and thin layer chromatography (HPTLC) densitometry methods as a stability indicating assays of olmesartan medoxomil in presence of its acid or alkaline induced degradation products were developed. Olmesartan medoxomil and its degradation products were analyzed by HPLC equipped with UV-Variable wave length detector at 257 nm where quantitation was achieved by isocratic elution on Agilent, Exclipse XDB- C column with mobile phase composed of acetonitrile: methanol: water: glacial acetic acid (40:35:25:0.1 v/v/v/v) at flow rate 1 ml min.-1. HPTLC was performed on aluminum packed Nano silica gel 60 F2J4 TLC plates as stationary phase with significant difference in R/ values between olmesartan medoxomil and its degradates using chloroform: methanol: formic acid (8:1.5:0.5 v/v/v) as mobile phase. Densitometric evaluation of intact drug was carried out at 260 nm. The calibration curve of olmesartan medoxomil in bulk form was linear from 0.5- 10 µg ml-1 and 0.05- 1 µg ml-1 with mean percentage accuracy 99.97 ± 1.085 % and 100.35 ± 1.060 % for HPLC and HPTLC methods, respectively. The two proposed methods were successfully applied for the determination of olmesartan medoxomil in drug substance and in drug product. Methods validation was tested for linearity; accuracy; precisión; selectivity and robustness, according to USP guidelines.
author	MOUSSA,BAHIA MOHAMED,MARWA YOUSSEF,NADIA
author_facet	MOUSSA,BAHIA MOHAMED,MARWA YOUSSEF,NADIA
author_sort	MOUSSA,BAHIA
title	ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS
title_short	ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS
title_full	ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS
title_fullStr	ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS
title_full_unstemmed	ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS
title_sort	acid- alkali degradation study on olmesartan medoxomil and development of validated stability-indicating chromatographic methods
publisher	Sociedad Chilena de Química
publishDate	2010
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200011
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ACID- ALKALI DEGRADATION STUDY ON OLMESARTAN MEDOXOMIL AND DEVELOPMENT OF VALIDATED STABILITY-INDICATING CHROMATOGRAPHIC METHODS

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