Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS

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dc.contributor.authorSchneider, Alex
dc.contributor.authorWessjohann, Ludger A.
dc.contributor.authorSeveri, Juliana A. [UNESP]
dc.contributor.authorWagner, Vilegas [UNESP]
dc.contributor.institutionIDrug GmbH
dc.contributor.institutionLeibniz Institute of Plant Biochemistry
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.date.accessioned2014-05-27T11:26:27Z
dc.date.available2014-05-27T11:26:27Z
dc.date.issued2012-04-30
dc.description.abstractComparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Hoffmann-La Roche Ltd., Switzerland) vs. generic (Lipiblock®, EMS-Sigma Pharma, a generic drug) were carried out with ethanol extracts of commercial samples. The generic formulation contained higher levels of common impurities as well as a considerable number of impurities not found in the reference product. The detected impurity profile of Lipiblock® revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical® appears to offer a better safety margin than Lipiblock® which, however, compares quite well to other generic formulations.en
dc.description.affiliationIDrug GmbH, Berlin
dc.description.affiliationDepartment of Bioorganic Chemistry Leibniz Institute of Plant Biochemistry, Halle (Saale)
dc.description.affiliationSchool of Pharmaceutical Sciences UNESP São Paulo State University, Araraquara
dc.description.affiliationInstitute of Chemistry UNESP São Paulo State University, Araraquara
dc.description.affiliationUnespSchool of Pharmaceutical Sciences UNESP São Paulo State University, Araraquara
dc.description.affiliationUnespInstitute of Chemistry UNESP São Paulo State University, Araraquara
dc.format.extent91-96
dc.identifierhttp://www.latamjpharm.org/resumenes/31/1/LAJOP_31_1_1_14.pdf
dc.identifier.citationLatin American Journal of Pharmacy, v. 31, n. 1, p. 91-96, 2012.
dc.identifier.issn0326-2383
dc.identifier.scopus2-s2.0-84860125323
dc.identifier.urihttp://hdl.handle.net/11449/73298
dc.language.isoeng
dc.relation.ispartofLatin American Journal of Pharmacy
dc.relation.ispartofjcr0.401
dc.relation.ispartofsjr0,152
dc.rights.accessRightsAcesso restrito
dc.sourceScopus
dc.subjectGenerics
dc.subjectHPLC-MS/MS
dc.subjectHPLC-UV
dc.subjectOrlistat
dc.subjectcobese
dc.subjectgeneric drug
dc.subjectlipiblock
dc.subjectorsoten
dc.subjectrotipuran
dc.subjectsuprapur
dc.subjecttetrahydrolipstatin
dc.subjectunclassified drug
dc.subjectcontrolled study
dc.subjectdrug formulation
dc.subjectdrug impurity
dc.subjectdrug safety
dc.subjectdrug structure
dc.subjectfermentation
dc.subjecthigh performance liquid chromatography
dc.subjectintermethod comparison
dc.subjectliquid chromatography
dc.subjectmass spectrometry
dc.titleComparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MSen
dc.typeArtigo

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