Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis

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dc.citation.titleJournal of Pharmaceutical and Biomedical Analysises
dc.citation.volume129(2016)es
dc.creatorCalvo, Natalia Lorena
dc.creatorArias, Juan Marcelo
dc.creatorBen Altabef, Aída
dc.creatorMaggio, Rubén Mariano
dc.creatorKaufman, Teodoro Saúl
dc.date.accessioned2020-02-10T22:33:56Z
dc.date.available2020-02-10T22:33:56Z
dc.date.issued2016-07-10
dc.descriptionAlbendazole (ALB) is a broad-spectrum anthelmintic, which exhibits two solid-state forms (Forms I and II). The Form I is the metastable crystal at room temperature, while Form II is the stable one. Because the drug has poor aqueous solubility and Form II is less soluble than Form I, it is desirable to have a method to assess the solid-state form of the drug employed for manufacturing purposes. Therefore, a Partial Least Squares (PLS) model was developed for the determination of Form I of ALB in its mixtures with Form II. For model development, both solid-state forms of ALB were prepared and characterized by microscopic (optical and with normal and polarized light), thermal (DSC) and spectroscopic (ATR-FTIR, Raman) techniques. Mixtures of solids in different ratios were prepared by weighing and mechanical mixing of the components. Their Raman spectra were acquired, and subjected to peak smoothing, normalization, standard normal variate correction and de-trending, before performing the PLS calculations. The optimal spectral region (1396–1280 cm−1) and number of latent variables (LV = 3) were obtained employing a moving window of variable size strategy. The method was internally validated by means of the leave one out procedure, providing satisfactory statistics (r2 = 0.9729 and RMSD = 5.6%) and figures of merit (LOD = 9.4% and MDDC = 1.4). Furthermore, the method’s performance was also evaluated by analysis of two validation sets. Validation set I was used for assessment of linearity and range and Validation set II, to demonstrate accuracy and precision (Recovery = 101.4% and RSD = 2.8%). Additionally, a third set of spiked commercial samples was evaluated, exhibiting excellent recoveries (94.2 ± 6.4%). The results suggest that the combination of Raman spectroscopy with multivariate analysis could be applied to the assessment of the main crystal form and its quantitation in samples of ALB bulk drug, in the routine quality control laboratoryes
dc.description.filFil: Calvo, Natalia Lorena. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Área de Análisis de Medicamentos; Argentina.es
dc.description.filFil: Calvo, Natalia Lorena. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUIR-CONICET); Argentina.es
dc.description.filFil: Arias, Juan Marcelo. Universidad Nacional de Tucumán. Facultad de Bioquímica, Química y Farmacia. Instituto de Química Física (INQUINOA-CONICET); Argentina.es
dc.description.filFil: Ben Altabef, Aída. Universidad Nacional de Tucumán. Facultad de Bioquímica, Química y Farmacia. Instituto de Química Física (INQUINOA-CONICET); Argentina.es
dc.description.filFil: Maggio, Rubén Mariano. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Área de Análisis de Medicamentos; Argentina.es
dc.description.filFil: Maggio, Rubén Mariano. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUIR-CONICET); Argentina.es
dc.description.filFil: Kaufman, Teodoro Saúl. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Área de Análisis de Medicamentos; Argentina.es
dc.description.filFil: Kaufman, Teodoro Saúl. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario (IQUIR-CONICET); Argentina.es
dc.description.sponsorshipConsejo Nacional de Investigaciones Científicas y Técnicas: PIP 2011-0471es
dc.description.sponsorshipAgencia Nacional de Promoción de Ciencia y Tecnología (ANPCyT): PICT 2014-005es
dc.description.sponsorshipSecretaría de Ciencia Tecnología e Innovación (SECTeI): Project 2010-085-11es
dc.description.sponsorshipSecretaría de Ciencia y Tecnología de la Universidad Nacional de Rosario (SECyT-UNR): Project BIO457es
dc.formatapplication/pdf
dc.format.extent190 - 197es
dc.identifier.issn0731-7085es
dc.identifier.urihttp://hdl.handle.net/2133/17590
dc.language.isoenges
dc.publisherElsevieres
dc.relation.publisherversionhttp://dx.doi.org/10.1016/j.jpba.2016.07.013es
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/pii/S0731708516303855?via%3Dihubes
dc.rightsopenAccesses
dc.rights.holderCalvo, Natalia Lorenaes
dc.rights.holderArias, Juan Marceloes
dc.rights.holderBen Altabef, Aídaes
dc.rights.holderMaggio, Rubén Marianoes
dc.rights.holderKaufman, Teodoro Saúles
dc.rights.holderElsevieres
dc.rights.holderUniversidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticases
dc.rights.holderUniversidad Nacional de Tucumán. Facultad de Bioquímica, Química y Farmaciaes
dc.rights.textAtribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0)es
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.es*
dc.subjectAlbendazolees
dc.subjectChemometricses
dc.subjectPLSes
dc.subjectRaman Spectroscopyes
dc.subjectSolid State Formses
dc.titleDetermination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysises
dc.typearticle
dc.typeartículo
dc.typepublishedVersion
dc.type.collectionarticulo
dc.type.versionpublishedVersiones

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