Figures Of Merit For The Determination Of The Polymorphic Purity Of Carbamazepine By Infrared Spectroscopy And Multivariate Calibration

dc.creatorBraga J.W.B.
dc.creatorPoppi R.J.
dc.date2004
dc.date2015-06-26T14:25:39Z
dc.date2015-11-26T14:15:15Z
dc.date2015-06-26T14:25:39Z
dc.date2015-11-26T14:15:15Z
dc.date.accessioned2018-03-28T21:16:08Z
dc.date.available2018-03-28T21:16:08Z
dc.identifier
dc.identifierJournal Of Pharmaceutical Sciences. , v. 93, n. 8, p. 2124 - 2134, 2004.
dc.identifier223549
dc.identifier10.1002/jps.20109
dc.identifierhttp://www.scopus.com/inward/record.url?eid=2-s2.0-3843092896&partnerID=40&md5=d60c97c7c9f013b91546dce9b944fb63
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/94816
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/94816
dc.identifier2-s2.0-3843092896
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1242748
dc.descriptionPolymorphism 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 Pharmacopoeia method). © 2004 Wiley-Liss, Inc. and the American Pharmacists Association.
dc.description93
dc.description8
dc.description2124
dc.description2134
dc.descriptionDunitz, J.D., Phase transitions in molecular crystals from a chemical viewpoint (1991) Pure Appl Chem, 63, pp. 177-185
dc.descriptionVerma, A.R., Krishna, P., (1966) Polymorphism and Polytypism in Crystals, pp. 7-30. , New York: Wiley
dc.descriptionEvans, R.C., (1966) An Introduction to Crystal Chemistry, p. 184. , New York: Cambridge University Press
dc.descriptionThrelfall, T.L., Analysis of organic polymorphs (1995) Analyst, 120, pp. 2435-2460
dc.descriptionOtsuka, M., Kato, F., Matsuda, Y., Determination of indomethacin polymorphic contents by chemometric near-infrared spectroscopy and conventional powder X-ray diffractometry (2001) Analyst, 126, pp. 1578-1582
dc.descriptionNorris, T., Aldridge, P.K., Sekulic, S.S., Determination of end-points for polymorph conversions of crystalline organic compounds using on-line near-infrared spectroscopy (1997) Analyst, 122, pp. 549-552
dc.descriptionBlanco, M., Villar, A., Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy (2000) Analyst, 125, pp. 2311-2314
dc.descriptionKaneko, F., Tashiro, K., Kobayashy, M., Polymorphic transformations during crystallization processes of fatty acid studied with FT-IR spectroscopy (1999) J Cryst Growth, 199, pp. 1352-1359
dc.descriptionAldridge, P.K., Evans, C.L., Ward, H.W., Colan, S.T., Near-IR detection of polymorphism and process-related substances (1996) Anal Chem, 68, pp. 997-1002
dc.descriptionBlanco, M., Villar, A., Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy (2000) Analyst, 125, pp. 2311-2314
dc.descriptionPatel, A.D., Paul, E.L., Kemper, M.S., Low-level determination of polymorphic composition in physical mixtures by near-infrared reflectance spectroscopy J Pharm Sci, 90 (3), pp. 360-369
dc.descriptionBorka, L., Lönmo, A., Winsnes, R., Semiquantitative IR spectroscopy of the crystal polymorphs of carbamazepine: A special case in the Ph. Eur. and USP (1992) Pharm Acta Helv, 8, pp. 231-233
dc.descriptionRustichelli, C., Gamberini, G., Ferioli, V., Gamberini, M.C., Ficarra, R., Tommasi, S., Solid-state study of polymorphic drugs: Carbamazepine (2000) J Pharm Biomed Anal, 23, pp. 41-54
dc.descriptionMartens, H., Naes, T., (1989) Multivariate Calibration, pp. 73-232. , New York: Wiley
dc.descriptionLee, K.R., Zuber, G., Katrincic, L., Chemometrics approach to the determination of polymorphism of a drug compound by infrared spectroscopy (2000) Drug Dev Ind Pharm, 26 (2), pp. 135-147
dc.descriptionInternational Conference on Harmonization, ICH harmonised tripartite guideline - Validation of analytical procedures: Methodology (1997) Fed Regist, 62, p. 27463
dc.descriptionInternational Conference on Harmonization, ICH harmonised tripartite guideline - Text on validation of analytical procedures (1995) Fed Regist, 60, p. 11260
dc.descriptionTrafford, A.D., Jee, R.D., Moffat, A.C., Graham, P., A rapid assay of intact paracetamol tablets by reflectance near-infrared spectroscopy (1999) Analyst, 124, pp. 163-167
dc.descriptionMoffat, A.C., Trafford, A.D., Jee, R.D., Graham, P., Meeting the International Conference on Harmonisation's Guidelines on Validation of Analytical Procedures: Quantification as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets (2000) Analyst, 125, pp. 1341-1351
dc.descriptionLaasonen, M., Pulkkinen, T.H., Simard, C., Rasanen, M., Vuorela, H., Development and validation of a near-infrared method for the quantitation of caffeine in intact single tablets (2003) Anal Chem, 75, pp. 754-760
dc.descriptionAnnual Book of ASTM Standards. 2000. Standard Practices for Infrared Multivariate Quantitative Analysis: E1655-00, , West Conshohocken, PA: ASTM International
dc.descriptionLorber, A., Faber, K., Kowalski, B.R., Net analyte signal calculation in multivariate calibration (1997) Anal Chem, 69, pp. 1620-1626
dc.descriptionFerré, J., Brown, S.D., Rius, F.X., Improved calculation of the net analyte signal in inverse multivariate calibration (2001) J Chemom, 15, pp. 357-553
dc.descriptionFaber, N.M., Efficient computation of net analyte signal vector in inverse multivariate calibration models (1998) Anal Chem, 70, pp. 5108-5110
dc.descriptionGoicoechea, H.C., Olivieri, A.C., A comparison of orthogonal signal correction and net analyte pre-processing methods, theoretical and experimental study (2001) Chemom Intell Lab Syst, 56, pp. 73-81
dc.descriptionFaber, N.M., Mean centering and computation of scalar net analyte signal in multivariate calibration (1998) J Chemom, 12, pp. 405-409
dc.descriptionCurrie, L.A., Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC recommendations 1995) (1999) Anal Chim Acta, 391, pp. 105-126
dc.descriptionVessman, J., Stefan, R.I., Van Staden, J.F., Danzer, K., Lindner, W., Burns, D.T., Fajgelj, A., Müller, H., Selectivity in analytical chemistry (IUPAC recommendations 2001) (2001) Pure Appl Chem, 73, pp. 1381-1386
dc.descriptionDe La Pena, A.M., Mansilla, A.E., Valenzuela, M.I.A., Goicoechea, H.C., Olivieri, A.C., Comparative study of net analyte signal-based methods and partial least squares for the simultaneous determination of amoxicillin and clavulatic acid by stopped-flow kinetic analysis (2002) Anal Chim Acta, 463, pp. 75-88
dc.descriptionHoy, M., Steen, K., Martens, H., Review of partial least squares regression prediction error in Unscrambler (1998) Chemom Intell Lab Syst, 44, pp. 123-133
dc.descriptionFaber, N.M., Bro, R., Standard error of prediction for multway PLS 1. Background and a simulation study (2002) Chemom Intell Lab Syst, 61, pp. 133-149
dc.descriptionJong, S., SIMPLS: An alternative approach to partial least squares regression (1993) J Chemom, 18, pp. 251-263
dc.descriptionVan Der Voet, H., Pseudo-degrees of freedom for complex predictive models: The example of partial least squares (1999) J Chemom, 13, pp. 195-208
dc.languageen
dc.publisher
dc.relationJournal of Pharmaceutical Sciences
dc.rightsfechado
dc.sourceScopus
dc.titleFigures Of Merit For The Determination Of The Polymorphic Purity Of Carbamazepine By Infrared Spectroscopy And Multivariate Calibration
dc.typeArtículos de revistas


Este ítem pertenece a la siguiente institución