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New perspectives of 19F MAS NMR in the characterization of amorphous forms of atorvastatin in dosage formulations
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SYSNO ASEP 0359458 Document Type J - Journal Article R&D Document Type Journal Article Subsidiary J Článek ve WOS Title New perspectives of 19F MAS NMR in the characterization of amorphous forms of atorvastatin in dosage formulations Author(s) Brus, Jiří (UMCH-V) RID, ORCID
Urbanová, Martina (UMCH-V) RID, ORCID
Šeděnková, Ivana (UMCH-V) RID
Brusová, H. (CZ)Source Title International Journal of Pharmaceutics. - : Elsevier - ISSN 0378-5173
Roč. 409, 1/2 (2011), s. 62-74Number of pages 13 s. Language eng - English Country GB - United Kingdom Keywords 19F MAS NMR ; factor analysis ; polymorphism Subject RIV CB - Analytical Chemistry, Separation R&D Projects 2B08021 GA MŠMT - Ministry of Education, Youth and Sports (MEYS) CEZ AV0Z40500505 - UMCH-V (2005-2011) UT WOS 000290135800008 DOI 10.1016/j.ijpharm.2011.02.030 Annotation Despite recent advances in solid-state NMR, the structural characterization of amorphous pharmaceuticals (APIs) in solid dosage forms continues to be a monumental challenge. To circumvent complications following from low concentrations of APIs in tablet formulations, we propose a new time-saving procedure based on chemometric approach: factor analysis of 19F MAS NMR spectra. Capability of the proposed method is demonstrated on atorvastatin – a typical representative of fluorinated pharmaceutical substances exhibiting extensive polymorphism. Applying the factor analysis on the recorded 19F MAS NMR spectra, unique parameters for every sample were derived. In this way every solid form of atorvastatin was characterized and clearly distinguishable even among various amorphous and disordered forms. Reliability of the proposed method was examined by comparing with other techniques and perspectives to obtain structural view on variability of amorphous products are also discussed. Workplace Institute of Macromolecular Chemistry Contact Eva Čechová, cechova@imc.cas.cz ; Tel.: 296 809 358 Year of Publishing 2012
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