SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD

A new, single, stability indicating RP-HPLC method has been developed and validated for the simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities i.e., related compound B and related compound C from combination drug product containing pioglitazone, glimepiride and metformin...

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Autores principales:	NAVANEETHAN,G, KARUNAKARAN,K, ELANGO,K. P
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2011
Materias:	stability indicating peak purity impurities validation
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000300021
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spelling	oai:scielo:S0717-970720110003000212012-01-11SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHODNAVANEETHAN,GKARUNAKARAN,KELANGO,K. P stability indicating peak purity impurities validation A new, single, stability indicating RP-HPLC method has been developed and validated for the simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities i.e., related compound B and related compound C from combination drug product containing pioglitazone, glimepiride and metformin HCl. The chromatographic separation was achieved on a cyano stationary phase (250 x 4.6mm, 5.0 microns particles) with simple mobile phase combination delivered in gradient mode at a flow rate of 0.8mL min¹ at 230nm. In the developed method, the critical close eluting compound of glimepiride related compound B and related compound C was found more than 6.5 resolutions. This method is capable to detect glimepiride related compound B and related compound C at a level below 0.005% with respect to glimepiride sample concentration of 0.1mg mL-1 for a 25 µL injection volume. The proposed method was validated according to the ICH guidelines and proved suitable for routine and stability analysis of these drugs in pharmaceutical preparations.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=S0717-97072011000300021en10.4067/S0717-97072011000300021
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	stability indicating peak purity impurities validation
spellingShingle	stability indicating peak purity impurities validation NAVANEETHAN,G KARUNAKARAN,K ELANGO,K. P SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD
description	A new, single, stability indicating RP-HPLC method has been developed and validated for the simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities i.e., related compound B and related compound C from combination drug product containing pioglitazone, glimepiride and metformin HCl. The chromatographic separation was achieved on a cyano stationary phase (250 x 4.6mm, 5.0 microns particles) with simple mobile phase combination delivered in gradient mode at a flow rate of 0.8mL min¹ at 230nm. In the developed method, the critical close eluting compound of glimepiride related compound B and related compound C was found more than 6.5 resolutions. This method is capable to detect glimepiride related compound B and related compound C at a level below 0.005% with respect to glimepiride sample concentration of 0.1mg mL-1 for a 25 µL injection volume. The proposed method was validated according to the ICH guidelines and proved suitable for routine and stability analysis of these drugs in pharmaceutical preparations.
author	NAVANEETHAN,G KARUNAKARAN,K ELANGO,K. P
author_facet	NAVANEETHAN,G KARUNAKARAN,K ELANGO,K. P
author_sort	NAVANEETHAN,G
title	SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD
title_short	SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD
title_full	SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD
title_fullStr	SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD
title_full_unstemmed	SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD
title_sort	simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities in combination drug product by a validated stability- indicating rp-hplc method
publisher	Sociedad Chilena de Química
publishDate	2011
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000300021
work_keys_str_mv	AT navaneethang simultaneousestimationofpioglitazoneglimepirideandglimepirideimpuritiesincombinationdrugproductbyavalidatedstabilityindicatingrphplcmethod AT karunakarank simultaneousestimationofpioglitazoneglimepirideandglimepirideimpuritiesincombinationdrugproductbyavalidatedstabilityindicatingrphplcmethod AT elangokp simultaneousestimationofpioglitazoneglimepirideandglimepirideimpuritiesincombinationdrugproductbyavalidatedstabilityindicatingrphplcmethod
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SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD

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