DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM

A new, simple, precise, and accurate high performance thin layer chromatography (HPTLC) densitometry method has been developed for simultaneous estimation of rosiglitazone maleate (ROSI) and glimepiride (GLIM) in tablet dosage form. Procedure does not require prior separation of components from the...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	DHOLE,SEEMA M, KHEDEKAR,PRAMOD B, AMNERKAR,NIKHIL D
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2013
Materias:	Rosiglitazone maleate Glimepiride HPTLC Densitometry Validation
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072013000200004
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:scielo:S0717-97072013000200004
record_format	dspace
spelling	oai:scielo:S0717-970720130002000042014-09-09DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORMDHOLE,SEEMA MKHEDEKAR,PRAMOD BAMNERKAR,NIKHIL D Rosiglitazone maleate Glimepiride HPTLC Densitometry Validation A new, simple, precise, and accurate high performance thin layer chromatography (HPTLC) densitometry method has been developed for simultaneous estimation of rosiglitazone maleate (ROSI) and glimepiride (GLIM) in tablet dosage form. Procedure does not require prior separation of components from the sample. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of methanol: toluene: ethyl acetate (1:8:1, v/v/v). Densitometric evaluation of the separated zones was performed at 228 nm. The drugs were satisfactorily resolved with Rf values 0.39 ± 0.03 and 0.20 ± 0.04 for ROSI and GLIM, respectively. Parameters such as linearity, precision, accuracy, recovery, specificity, and ruggedness were studied as reported in the International Conference on Harmonization (ICH) guidelines. The linearity regression analysis for calibration showed correlation coefficients R² valve 0.9989 and 0.9996 for ROSI and GLIM, respectively with respect to peak area in the concentration range of 100-1500 ng/spot. The mean percentage recovery values were close to 100 %, it indicates that there is no interferences of additives with ROSI and GLIM present in tablet dosage form. Statistical analysis proved that the method is suitable for the quality control analysis of ROSI and GLIM as a bulk drug and in pharmaceutical formulations. The study may be extended to comprehend the degradation kinetics of these two drugs.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.58 n.2 20132013-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072013000200004en10.4067/S0717-97072013000200004
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Rosiglitazone maleate Glimepiride HPTLC Densitometry Validation
spellingShingle	Rosiglitazone maleate Glimepiride HPTLC Densitometry Validation DHOLE,SEEMA M KHEDEKAR,PRAMOD B AMNERKAR,NIKHIL D DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM
description	A new, simple, precise, and accurate high performance thin layer chromatography (HPTLC) densitometry method has been developed for simultaneous estimation of rosiglitazone maleate (ROSI) and glimepiride (GLIM) in tablet dosage form. Procedure does not require prior separation of components from the sample. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of methanol: toluene: ethyl acetate (1:8:1, v/v/v). Densitometric evaluation of the separated zones was performed at 228 nm. The drugs were satisfactorily resolved with Rf values 0.39 ± 0.03 and 0.20 ± 0.04 for ROSI and GLIM, respectively. Parameters such as linearity, precision, accuracy, recovery, specificity, and ruggedness were studied as reported in the International Conference on Harmonization (ICH) guidelines. The linearity regression analysis for calibration showed correlation coefficients R² valve 0.9989 and 0.9996 for ROSI and GLIM, respectively with respect to peak area in the concentration range of 100-1500 ng/spot. The mean percentage recovery values were close to 100 %, it indicates that there is no interferences of additives with ROSI and GLIM present in tablet dosage form. Statistical analysis proved that the method is suitable for the quality control analysis of ROSI and GLIM as a bulk drug and in pharmaceutical formulations. The study may be extended to comprehend the degradation kinetics of these two drugs.
author	DHOLE,SEEMA M KHEDEKAR,PRAMOD B AMNERKAR,NIKHIL D
author_facet	DHOLE,SEEMA M KHEDEKAR,PRAMOD B AMNERKAR,NIKHIL D
author_sort	DHOLE,SEEMA M
title	DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM
title_short	DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM
title_full	DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM
title_fullStr	DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM
title_full_unstemmed	DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM
title_sort	development and validation of hptlc densitometry method for simultaneous estimation of rosiglitazone and glimepiride in fixed tablet dosage form
publisher	Sociedad Chilena de Química
publishDate	2013
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072013000200004
work_keys_str_mv	AT dholeseemam developmentandvalidationofhptlcdensitometrymethodforsimultaneousestimationofrosiglitazoneandglimepirideinfixedtabletdosageform AT khedekarpramodb developmentandvalidationofhptlcdensitometrymethodforsimultaneousestimationofrosiglitazoneandglimepirideinfixedtabletdosageform AT amnerkarnikhild developmentandvalidationofhptlcdensitometrymethodforsimultaneousestimationofrosiglitazoneandglimepirideinfixedtabletdosageform
_version_	1718445485121863680

DEVELOPMENT AND VALIDATION OF HPTLC DENSITOMETRY METHOD FOR SIMULTANEOUS ESTIMATION OF ROSIGLITAZONE AND GLIMEPIRIDE IN FIXED TABLET DOSAGE FORM

Ejemplares similares