A fast and sensitive UHPLC-MS/ MS method for the determination of N-butylscopolamine in human plasma: application in a bioequivalence study

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dc.citation.issue3
dc.citation.volume31
dc.contributor.authorSuenaga, Eunice Mayumi [UNIFESP]
dc.contributor.authorVal, Ligia de Cassia
dc.contributor.authorTominaga, Mineko
dc.contributor.authorSouza Filho, Jose Homero
dc.contributor.authorSoares, Gidel
dc.contributor.authorVioto, Monalisa
dc.contributor.authorNakaie, Clovis Ryuichi [UNIFESP]
dc.coverageHoboken
dc.date.accessioned2020-07-17T14:02:44Z
dc.date.available2020-07-17T14:02:44Z
dc.date.issued2017
dc.description.abstractWe have developed and validated a fast and sensitive ultra high-performance liquid chromatography with positive ion electrospray ionization tandem mass spectrometry method for determining N-butylscopolamine levels in human plasma using propranolol as an internal standard.The acquisition was set up in the multiple reaction monitoring mode with the transitions m/ z 360.3.138.0 for N-butylscopolamine and m/ z 260.2.116.1 for IS.This method uses a liquid-liquid extraction process with dichloromethane.The analyte and IS were chromatographed on a C18, 50x2.1 mm, 1.7 mu m column through isocratic elution with acetonitrile- 5mM ammonium acetate (adjusted to pH 3.0 with formic acid).The method was linear in the 1-1000 pg/ mL range for N-butylscopolamine and was selective, precise, accurate and robust.The validated method was successfully applied to perform a bioequivalence study of the reference (Buscopan r, from Boehringer Ingelheim) and the test sample coated-tablet formulations (from Foundation for Popular Remedy), both containing 10 mg of N-butylscopolamine bromide administered as a single dose.Using 58 healthy volunteers and accounting for the high intra-individual variability confirmed by statistical calculations (38%), the two formulations were considered bioequivalent because the rate and extent of absorption (within 80-125% interval), satisfying international requirements.en
dc.description.affiliationUniv Fed Sao Paulo, Escola Paulista Med, Dept Biofis, Nucleo Bioequivalencia & Ensaios Clin, Sao Paulo, SP, Brazil
dc.description.affiliationAssociacao Paulista Desenvolvimento Med, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Fed Pernambuco, Nucleo Desenvolvimento Farmaceut & Cosmet, Recife, PE, Brazil
dc.description.affiliationSecretaria Saude Estado Sao Paulo, Fundacao Remedio Popular, Sao Paulo, SP, Brazil
dc.description.affiliationUnifespUniv Fed Sao Paulo, Escola Paulista Med, Dept Biofis, Nucleo Bioequivalencia & Ensaios Clin, Sao Paulo, SP, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipNational Council for Scientific and Tecnological Development (CNPq)
dc.description.sponsorshipFURP and Nucleo de Desenvolvimento Farmaceutico e Cosmpetico
dc.format.extent-
dc.identifierhttp://dx.doi.org/10.1002/bmc.3823
dc.identifier.citationBiomedical Chromatography. Hoboken, v. 31, n. 3, p. -, 2017.
dc.identifier.doi10.1002/bmc.3823
dc.identifier.issn0269-3879
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/54983
dc.identifier.wosWOS:000398912500014
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofBiomedical Chromatography
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectbioequivalenceen
dc.subjecthuman plasmaen
dc.subjectN-butylscopolamineen
dc.subjectpharmacokinetic studyen
dc.subjectUHPLC-MS/ MSen
dc.titleA fast and sensitive UHPLC-MS/ MS method for the determination of N-butylscopolamine in human plasma: application in a bioequivalence studyen
dc.typeinfo:eu-repo/semantics/article
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