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dc.creatorGrigori, Katerina
dc.creatorLoukas, Yannis L.
dc.creatorMalenović, Anđelija
dc.creatorSamara, Vicky
dc.creatorKalaskani, Anastasia
dc.creatorDimovasili, Efi
dc.creatorKalovidouri, Magda
dc.creatorDotsikas, Yannis
dc.date.accessioned2019-09-02T11:58:13Z
dc.date.available2019-09-02T11:58:13Z
dc.date.issued2017
dc.identifier.issn0731-7085
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2832
dc.description.abstractA sensitive Liquid Chromatography tandem mass spectrometry (LC MS/MS) method was developed and validated for the quantitative analysis of three potential genotoxic impurities (318BP, M9, S5) in meropenem Active Pharmaceutical Ingredient (API). Due to the requirement for LOD values in ppb range, a high concentration of meropenem API (30 ing/mL) had to be injected. Therefore, efficient determination of meropenem from its impurities became a critical aim of this study, in order to divert meropenem to waste, via a switching valve. After the selection of the important factors affecting analytes' elution, a Box-Behnken design was utilized to set the plan of experiments conducted with UV detector. As responses, the separation factors between the last eluting impurity and meropenem, as well as meropenem retention factor k were used. Grid point search methodology was implemented aiming to obtain the optimal conditions that simultaneously comply to the conflicted criteria. Optimal mobile phase consisted of ACN, methanol and 0.09% HCOOH at a ratio 71/3.5/15.5 v/v. All impurities and internal standard omeprazole were eluted before 7.5 min and at 8.0 min the eluents were directed to waste. The protocol was transferred to LC-MS/MS and validated according to ICH guidelines.en
dc.publisherElsevier Science BV, Amsterdam
dc.rightsrestrictedAccess
dc.sourceJournal of Pharmaceutical and Biomedical Analysis
dc.subjectMeropenemen
dc.subjectLC-MS/MSen
dc.subjectGenotoxk impuritiesen
dc.subjectBox-Behnkenen
dc.subjectGrid point search methodologyen
dc.titleChemometrically assisted development and validation of LC-MS/MS method for the analysis of potential genotoxic impurities in meropenem active pharmaceutical ingredienten
dc.typearticle
dc.rights.licenseARR
dcterms.abstractКаласкани, Aнастасиа; Самара, Вицкy; Каловидоури, Магда; Григори, Катерина; Дотсикас, Yаннис; Маленовић, Aнђелија; Лоукас, Yаннис Л.; Димовасили, Ефи;
dc.citation.volume145
dc.citation.spage307
dc.citation.epage314
dc.citation.other145: 307-314
dc.citation.rankM21
dc.identifier.wos000410872200038
dc.identifier.doi10.1016/j.jpba.2017.06.061
dc.identifier.pmid28709127
dc.identifier.scopus2-s2.0-85022201663
dc.identifier.rcubconv_3945
dc.type.versionpublishedVersion


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