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Development and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms

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dc.contributor.authorKARAKUŞ, SEVGİ
dc.contributor.authorsKarakus, Sevgi; Kuecuekguezel, Ilkay; Kuecuekguezel, S. Gueniz
dc.date.accessioned2022-03-12T17:33:35Z
dc.date.available2022-03-12T17:33:35Z
dc.date.issued2008
dc.description.abstractThe objective of the current study was to develop a simple, accurate, precise and rapid reversed-phase HPLC method and subsequent validation using ICH suggested approach for the determination of antihistaminic-decongestant pharmaceutical dosage forms containing binary mixtures of pseudoephedrine hydrochloride (PSE) with fexofenadine hydrochloride (FEX) or cetirizine dihydrochloride (CET). The chromatographic separation of PSE, FEX and CET was achieved on a Zorbax C8 (150 mm x 4.6 mm; 5 mu m particle size) column using UV detection at 218 and 222 nm. The optimized mobile phase was consisted of TEA solution (0.5%, pH 4.5)-methanol-acetonitrile (50:20:30, v/v/v). The retention times were 1.099, 2.714 and 3.808 min for PSE, FEX and CET, respectively. The proposed method provided linear responses within the concentration ranges 30-240 and 1.25-10 mu g ml(-1) with LOD values of 1.75 and 0. 10 mu g ml(-1) for PSE and CET, respectively. Linearity range for PSE-FEX binary mixtures were 10-80 and 5-40 mu g ml(-1) with LOD values of 0.75 and 0.27 mu g ml(-1) for PSE and FEX, respectively. Correlation coefficients (r) of the regression equations were greater than 0.999 in all cases. The precision of the method was demonstrated using intra- and inter-day assay R.S.D. values which were less than 1% in all instances. No interference from any components of pharmaceutical dosage forms or degradation products was observed. According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the quantitative analysis of these drugs in capsules containing PSE-CET or extended-release tablets containing PSE-FEX binary mixtures. (C) 2007 Elsevier B.V. All rights reserved.
dc.identifier.doi10.1016/j.jpba.2007.10.018
dc.identifier.eissn1873-264X
dc.identifier.issn0731-7085
dc.identifier.pubmed18054459
dc.identifier.urihttps://hdl.handle.net/11424/228873
dc.identifier.wosWOS:000253011400012
dc.language.isoeng
dc.publisherELSEVIER SCIENCE BV
dc.relation.ispartofJOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.subjectcetirizine
dc.subjectfexofenadine
dc.subjectpseudoephedrine
dc.subjectreversed-phase HPLC
dc.subjectvalidation
dc.subjectLIQUID-CHROMATOGRAPHIC DETERMINATION
dc.subjectSEASONAL ALLERGIC RHINITIS
dc.subjectHUMAN PLASMA
dc.subjectCAPILLARY-ELECTROPHORESIS
dc.subjectDERIVATIVE SPECTROPHOTOMETRY
dc.subjectPHARMACOLOGICAL PROPERTIES
dc.subjectHYDROCHLORIDE
dc.subjectDIHYDROCHLORIDE
dc.subjectTABLETS
dc.subjectFORMULATIONS
dc.titleDevelopment and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms
dc.typearticle
dspace.entity.typePublication
local.avesis.ide8191517-0fa2-44e1-afb4-8091df21fb95
local.import.packageSS17
local.indexed.atWOS
local.indexed.atSCOPUS
local.indexed.atPUBMED
local.journal.numberofpages8
oaire.citation.endPage302
oaire.citation.issue2
oaire.citation.startPage295
oaire.citation.titleJOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
oaire.citation.volume46
relation.isAuthorOfPublicationc93b8083-3f67-4147-bd81-8587eaba18ad
relation.isAuthorOfPublication.latestForDiscoveryc93b8083-3f67-4147-bd81-8587eaba18ad

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