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Type: Artigo de periódico
Title: Figures Of Merit For The Determination Of The Polymorphic Purity Of Carbamazepine By Infrared Spectroscopy And Multivariate Calibration.
Author: Braga, Jez Willian B
Poppi, Ronei Jesus
Abstract: Polymorphism is an important property in the quality control of pharmaceutical products. In this regard, partial least squares regression and the net analytical signal were used to build and validate a multivariate calibration model using diffuse reflectance infrared spectroscopy in the region of 900-1100 cm(-1) for the determination of the polymorphic purity of carbamazepine. Physical mixtures of the polymorphs were made by weight, from 80 to 100% (w/w) form III mixed with form I. Figures of merit, such as sensitivity, analytical sensitivity, selectivity, confidence limits, precision (mean, repeatability, intermediate), accuracy, and signal-to-noise ratio were calculated. Feasible results were obtained with maximum absolute error of 2% and an average error of 0.53%, indicating that the proposed methodology can be used by the pharmaceutical industry as an alternative to the X-ray diffraction (United States Pharmacopoeiamethod).
Subject: Calibration
Multivariate Analysis
Reproducibility Of Results
Sensitivity And Specificity
Spectrophotometry, Infrared
Citation: Journal Of Pharmaceutical Sciences. v. 93, n. 8, p. 2124-34, 2004-Aug.
Rights: fechado
Identifier DOI: 10.1002/jps.20109
Date Issue: 2004
Appears in Collections:Unicamp - Artigos e Outros Documentos

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