A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES

Present work describes development and validation of HPLC-DAD method for the analysis of a complex mixture consisting phenylephrine hydrochloride (PHE), paracetamol (PAR), caffeine (CAF) and levocetirizine (LEV). Chromatographic separation was achieved using a Kinetex-C18 column involving gradient e...

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Autores principales:	DEWANI,ANIL P, PATRA,SRDHANJALI
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2015
Materias:	phenylephrine paracetamol caffeine levocetirizine HPLC-DAD
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072015000400019
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spelling	oai:scielo:S0717-970720150004000192016-02-23A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIESDEWANI,ANIL PPATRA,SRDHANJALI phenylephrine paracetamol caffeine levocetirizine HPLC-DAD Present work describes development and validation of HPLC-DAD method for the analysis of a complex mixture consisting phenylephrine hydrochloride (PHE), paracetamol (PAR), caffeine (CAF) and levocetirizine (LEV). Chromatographic separation was achieved using a Kinetex-C18 column involving gradient elution, the mobile phase composed of 10mM phosphate buffer (pH 3.3) and methanol. The three step gradient program started with step-1 initially with 2% (by volume) methanol and 98 % phosphate buffer (pH 3.3) for first 5 minutes. In step-2 methanol concentration changed linearly to 80% in next 12 minutes the analysis was concluded by step-3 changing methanol to 2% in next 8 minutes. The method was linear in concentration ranges of 50 to 200 % of labeled claims with r² near to 1. Developed method proved to be precise for inter and intra-day studies the %RSD values were < 2 , accuracy studies by standard addition at 80, 100 and 120% levels resulted in recoveries of standard near to 100%. The method was selective with no interferences from placebo; robustness of method was proved by no significant alteration in system suitability parameters. The LOD values for PHE, PAR, CAF and LEV were 0.13, 0.51, 0.05 and 0.05 and LOQ were 0.39, 1.53, 0.15 and 0.15 respectively. The study concluded a validated HPLC method for analysis of complex mixture consisting PHE, PAR, CAF and LEV in bulk, tablet and dissolution samples in simulated gastric fluid (SGF).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=S0717-97072015000400019en10.4067/S0717-97072015000400019
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	phenylephrine paracetamol caffeine levocetirizine HPLC-DAD
spellingShingle	phenylephrine paracetamol caffeine levocetirizine HPLC-DAD DEWANI,ANIL P PATRA,SRDHANJALI A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES
description	Present work describes development and validation of HPLC-DAD method for the analysis of a complex mixture consisting phenylephrine hydrochloride (PHE), paracetamol (PAR), caffeine (CAF) and levocetirizine (LEV). Chromatographic separation was achieved using a Kinetex-C18 column involving gradient elution, the mobile phase composed of 10mM phosphate buffer (pH 3.3) and methanol. The three step gradient program started with step-1 initially with 2% (by volume) methanol and 98 % phosphate buffer (pH 3.3) for first 5 minutes. In step-2 methanol concentration changed linearly to 80% in next 12 minutes the analysis was concluded by step-3 changing methanol to 2% in next 8 minutes. The method was linear in concentration ranges of 50 to 200 % of labeled claims with r² near to 1. Developed method proved to be precise for inter and intra-day studies the %RSD values were < 2 , accuracy studies by standard addition at 80, 100 and 120% levels resulted in recoveries of standard near to 100%. The method was selective with no interferences from placebo; robustness of method was proved by no significant alteration in system suitability parameters. The LOD values for PHE, PAR, CAF and LEV were 0.13, 0.51, 0.05 and 0.05 and LOQ were 0.39, 1.53, 0.15 and 0.15 respectively. The study concluded a validated HPLC method for analysis of complex mixture consisting PHE, PAR, CAF and LEV in bulk, tablet and dissolution samples in simulated gastric fluid (SGF).
author	DEWANI,ANIL P PATRA,SRDHANJALI
author_facet	DEWANI,ANIL P PATRA,SRDHANJALI
author_sort	DEWANI,ANIL P
title	A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES
title_short	A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES
title_full	A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES
title_fullStr	A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES
title_full_unstemmed	A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES
title_sort	single hplc-dad method for simultaneous analysis of paracetamol, phenylephrine, caffeine and levocetirizine in bulk powder and tablet formulation: application to in-vitro dissolution studies
publisher	Sociedad Chilena de Química
publishDate	2015
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072015000400019
work_keys_str_mv	AT dewanianilp asinglehplcdadmethodforsimultaneousanalysisofparacetamolphenylephrinecaffeineandlevocetirizineinbulkpowderandtabletformulationapplicationtoinvitrodissolutionstudies AT patrasrdhanjali asinglehplcdadmethodforsimultaneousanalysisofparacetamolphenylephrinecaffeineandlevocetirizineinbulkpowderandtabletformulationapplicationtoinvitrodissolutionstudies AT dewanianilp singlehplcdadmethodforsimultaneousanalysisofparacetamolphenylephrinecaffeineandlevocetirizineinbulkpowderandtabletformulationapplicationtoinvitrodissolutionstudies AT patrasrdhanjali singlehplcdadmethodforsimultaneousanalysisofparacetamolphenylephrinecaffeineandlevocetirizineinbulkpowderandtabletformulationapplicationtoinvitrodissolutionstudies
_version_	1718445545101459456

A SINGLE HPLC-DAD METHOD FOR SIMULTANEOUS ANALYSIS OF PARACETAMOL, PHENYLEPHRINE, CAFFEINE AND LEVOCETIRIZINE IN BULK POWDER AND TABLET FORMULATION: APPLICATION TO IN-VITRO DISSOLUTION STUDIES

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