VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE

A simple, rapid and robust LC method was developed and validated for the enantiomeric separation of dexrabeprazole in bulk drug and formulation. The enantiomers of dexrabeprazole were resolved on a Chiralpak AD-RH (amylose based stationary phase) column using a mobile phase consisting of water: acet...

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Autores principales:	PATIL,KIRAN R, RANE,VIPUL P, YEOLE,RAVINDRA D, SANGSHETTI,JAIPRAKASH N, SHINDE,DEVANAND B
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2011
Materias:	Dexrabeprazole Chiral HPLC Enantiomer Validation
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000200018
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spelling	oai:scielo:S0717-970720110002000182011-09-01VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASEPATIL,KIRAN RRANE,VIPUL PYEOLE,RAVINDRA DSANGSHETTI,JAIPRAKASH NSHINDE,DEVANAND B Dexrabeprazole Chiral HPLC Enantiomer Validation A simple, rapid and robust LC method was developed and validated for the enantiomeric separation of dexrabeprazole in bulk drug and formulation. The enantiomers of dexrabeprazole were resolved on a Chiralpak AD-RH (amylose based stationary phase) column using a mobile phase consisting of water: acetonitrile (50:50, v/v) at a flow rate of 0.5 ml min¹. The resolution between the enantiomers was found to be more than 1.5 in optimized method. The developed method was extensively validated and proved to be robust. The calibration curve for (S)-enantiomer showed excellent linearity over the concentration range of 0.05 µg ml¹ (LOQ) to 1 µg ml¹. The limit of detection and limit of quantification for (S)-enantiomer were 0.015 µg ml¹ and 0.05 µg ml¹, respectively. The percentage recovery of the (S)-enantiomer ranged between 97 to 101 % in bulk drug samples of dexrabeprazole. The proposed method was found to be suitable and accurate for quantitative determination of (S)-enantiomer in bulk drug substance.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.56 n.2 20112011-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000200018en10.4067/S0717-97072011000200018
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Dexrabeprazole Chiral HPLC Enantiomer Validation
spellingShingle	Dexrabeprazole Chiral HPLC Enantiomer Validation PATIL,KIRAN R RANE,VIPUL P YEOLE,RAVINDRA D SANGSHETTI,JAIPRAKASH N SHINDE,DEVANAND B VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
description	A simple, rapid and robust LC method was developed and validated for the enantiomeric separation of dexrabeprazole in bulk drug and formulation. The enantiomers of dexrabeprazole were resolved on a Chiralpak AD-RH (amylose based stationary phase) column using a mobile phase consisting of water: acetonitrile (50:50, v/v) at a flow rate of 0.5 ml min¹. The resolution between the enantiomers was found to be more than 1.5 in optimized method. The developed method was extensively validated and proved to be robust. The calibration curve for (S)-enantiomer showed excellent linearity over the concentration range of 0.05 µg ml¹ (LOQ) to 1 µg ml¹. The limit of detection and limit of quantification for (S)-enantiomer were 0.015 µg ml¹ and 0.05 µg ml¹, respectively. The percentage recovery of the (S)-enantiomer ranged between 97 to 101 % in bulk drug samples of dexrabeprazole. The proposed method was found to be suitable and accurate for quantitative determination of (S)-enantiomer in bulk drug substance.
author	PATIL,KIRAN R RANE,VIPUL P YEOLE,RAVINDRA D SANGSHETTI,JAIPRAKASH N SHINDE,DEVANAND B
author_facet	PATIL,KIRAN R RANE,VIPUL P YEOLE,RAVINDRA D SANGSHETTI,JAIPRAKASH N SHINDE,DEVANAND B
author_sort	PATIL,KIRAN R
title	VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
title_short	VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
title_full	VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
title_fullStr	VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
title_full_unstemmed	VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
title_sort	validated chiral lc method for dexrabeprazole on reverse phase amylose based stationary phase
publisher	Sociedad Chilena de Química
publishDate	2011
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072011000200018
work_keys_str_mv	AT patilkiranr validatedchirallcmethodfordexrabeprazoleonreversephaseamylosebasedstationaryphase AT ranevipulp validatedchirallcmethodfordexrabeprazoleonreversephaseamylosebasedstationaryphase AT yeoleravindrad validatedchirallcmethodfordexrabeprazoleonreversephaseamylosebasedstationaryphase AT sangshettijaiprakashn validatedchirallcmethodfordexrabeprazoleonreversephaseamylosebasedstationaryphase AT shindedevanandb validatedchirallcmethodfordexrabeprazoleonreversephaseamylosebasedstationaryphase
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VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE

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