Calibration transfer from powder mixtures to intact tablets: a new use in pharmaceutical analysis for a known tool

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dc.creatorLeandro Soares Alves Pereira
dc.creatorMaíra Ferreira Carneiro
dc.creatorBruno Gonçalves Botelho
dc.creatorMarcelo Martins de Sena
dc.date.accessioned2022-02-21T18:19:41Z
dc.date.accessioned2025-09-09T00:13:33Z
dc.date.available2022-02-21T18:19:41Z
dc.date.issued2016
dc.description.sponsorshipCAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
dc.format.mimetypepdf
dc.identifier.doi10.1016/j.talanta.2015.10.006
dc.identifier.issn00399140
dc.identifier.urihttps://hdl.handle.net/1843/39522
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofTalanta
dc.rightsAcesso Aberto
dc.subjectMedicamentos
dc.subject.otherCalibration transfer
dc.subject.otherDouble window piecewise direct standardization
dc.subject.otherIntact tablets
dc.subject.otherNear-infrared spectroscopy
dc.subject.otherPharmaceutical quality control
dc.subject.otherNevirapine
dc.titleCalibration transfer from powder mixtures to intact tablets: a new use in pharmaceutical analysis for a known tool
dc.typeArtigo de periódico
local.citation.epage357
local.citation.spage351
local.citation.volume147
local.description.resumoCalibration transfer is commonly used for spectra obtained in different spectrometers or other conditions. This paper proposed the use of calibration transfer between spectra recorded for the same samples in different physical forms. A new method was developed for the direct determination of nevirapine in solid pharmaceutical formulations based on diffuse reflectance near infrared spectroscopy (NIRS) and partial least squares (PLS). This method was developed with 50 powder mixtures and then, successfully extended to the quantification in intact tablets by using calibration transfer with double window piecewise direct standardization (DWPDS). This chemometric strategy provided good results with a small number of tablet transfer samples, only seven, prepared out of the narrow range of active principle ingredients (API) content around the nominal value of the formulation (100%). The method was fully validated in the working range of 83.0–113.9% of nevirapine and the use of DWPDS allowed to significantly decreasing the root mean square error of prediction (RMSEP) from 4.8% (tablets predicted by a model built with only powder samples) to 2.6%. The range of relative errors decreased from −5.1/8.7% to −4.6/3.3%. Considering that the amount of raw materials demanded for preparing tablets is up to ten times higher than for powder mixtures, this type of application is of particular interest in pharmaceutical analysis. In the context of process analytical technology (PAT), the use of the same multivariate model in different steps of the production is very advantageous, saving time and labor.
local.publisher.countryBrasil
local.publisher.departmentFAR - DEPARTAMENTO DE ALIMENTOS
local.publisher.departmentICX - DEPARTAMENTO DE QUÍMICA
local.publisher.initialsUFMG
local.url.externahttps://www.sciencedirect.com/science/article/pii/S0039914015303726?via%3Dihub

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