SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD

A selective, rapid, isocratic RP-HPLC method has been developed and validated for the simultaneous determination of the cough suppressant drug levodropropizine and its two co-formulated preservatives methylparaben and propylparaben in Levopront® syrups. The chromatographic separation was achieved on...

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Autores principales:	WESHAHY,SOHEIR ABD EL-FATAH, YAAQOB,MAISSA SALEM, MORCOS,MARIANNE NEBSEN, HASSAN,DINA WAHBA, YOUSSEF,NADIA FAYEK
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2015
Materias:	Levodropropizine Methylparaben Propylparaben RP-HPLC Method Validation
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072015000400018
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spelling	oai:scielo:S0717-970720150004000182016-02-23SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHODWESHAHY,SOHEIR ABD EL-FATAHYAAQOB,MAISSA SALEMMORCOS,MARIANNE NEBSENHASSAN,DINA WAHBAYOUSSEF,NADIA FAYEK Levodropropizine Methylparaben Propylparaben RP-HPLC Method Validation A selective, rapid, isocratic RP-HPLC method has been developed and validated for the simultaneous determination of the cough suppressant drug levodropropizine and its two co-formulated preservatives methylparaben and propylparaben in Levopront® syrups. The chromatographic separation was achieved on Inertsil® C18, (250 mm x 4.6mm, 5um) column using a mixture of (acetonitrile: 0.1 % triethylamine in water, pH 3.0) 50:50: (v/v), as a mobile phase with a flow rate of 1.0 ml/min, at 30° C column temperature and detector wavelength of 240 nm. All peaks were symmetrical and well resolved in a short run time. Method validation demonstrated to be selective, accurate and precise with good linearity over the concentration range of (7.5-60 μg/ml), (1.625-13 μg/ml), and (0.25-2 μg/ ml) with limits of detection and quantification of 0.502 and 1.520 μg/ml, 0.071 and 0.215 μg/ml, and 0.040 and 0.122 μg/ml for Levodropropizine, Methylparaben, and Propylparaben, respectively. Robustness against small modifications of column temperature, flow rate and pH of the mobile phase was ascertained. The developed method was successfully applied for the separation and quantification of Levodropropizine in presence of its two co-formulated preservatives in drug substances and in Levopront® oral pharmaceutical formulation; therefore it's highly suitable for routine analysis in QC labs.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.60 n.4 20152015-12-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072015000400018en10.4067/S0717-97072015000400018
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Levodropropizine Methylparaben Propylparaben RP-HPLC Method Validation
spellingShingle	Levodropropizine Methylparaben Propylparaben RP-HPLC Method Validation WESHAHY,SOHEIR ABD EL-FATAH YAAQOB,MAISSA SALEM MORCOS,MARIANNE NEBSEN HASSAN,DINA WAHBA YOUSSEF,NADIA FAYEK SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD
description	A selective, rapid, isocratic RP-HPLC method has been developed and validated for the simultaneous determination of the cough suppressant drug levodropropizine and its two co-formulated preservatives methylparaben and propylparaben in Levopront® syrups. The chromatographic separation was achieved on Inertsil® C18, (250 mm x 4.6mm, 5um) column using a mixture of (acetonitrile: 0.1 % triethylamine in water, pH 3.0) 50:50: (v/v), as a mobile phase with a flow rate of 1.0 ml/min, at 30° C column temperature and detector wavelength of 240 nm. All peaks were symmetrical and well resolved in a short run time. Method validation demonstrated to be selective, accurate and precise with good linearity over the concentration range of (7.5-60 μg/ml), (1.625-13 μg/ml), and (0.25-2 μg/ ml) with limits of detection and quantification of 0.502 and 1.520 μg/ml, 0.071 and 0.215 μg/ml, and 0.040 and 0.122 μg/ml for Levodropropizine, Methylparaben, and Propylparaben, respectively. Robustness against small modifications of column temperature, flow rate and pH of the mobile phase was ascertained. The developed method was successfully applied for the separation and quantification of Levodropropizine in presence of its two co-formulated preservatives in drug substances and in Levopront® oral pharmaceutical formulation; therefore it's highly suitable for routine analysis in QC labs.
author	WESHAHY,SOHEIR ABD EL-FATAH YAAQOB,MAISSA SALEM MORCOS,MARIANNE NEBSEN HASSAN,DINA WAHBA YOUSSEF,NADIA FAYEK
author_facet	WESHAHY,SOHEIR ABD EL-FATAH YAAQOB,MAISSA SALEM MORCOS,MARIANNE NEBSEN HASSAN,DINA WAHBA YOUSSEF,NADIA FAYEK
author_sort	WESHAHY,SOHEIR ABD EL-FATAH
title	SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD
title_short	SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD
title_full	SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD
title_fullStr	SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD
title_full_unstemmed	SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD
title_sort	simultaneous determination of levodropropizine, methylparaben, and propylparaben in oral co-formulated syrup by rp-hplc method
publisher	Sociedad Chilena de Química
publishDate	2015
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072015000400018
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SIMULTANEOUS DETERMINATION OF LEVODROPROPIZINE, METHYLPARABEN, AND PROPYLPARABEN IN ORAL CO-FORMULATED SYRUP BY RP-HPLC METHOD

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