New perspectives of 19F MAS NMR in the characterization of amorphous forms of atorvastatin in dosage formulations

0359458 - ÚMCH 2012 RIV GB eng J - Journal Article
Brus, Jiří - Urbanová, Martina - Šeděnková, Ivana - Brusová, H.
New perspectives of 19F MAS NMR in the characterization of amorphous forms of atorvastatin in dosage formulations.
International Journal of Pharmaceutics. Roč. 409, 1/2 (2011), s. 62-74. ISSN 0378-5173. E-ISSN 1873-3476
R&D Projects: GA MŠMT 2B08021
Institutional research plan: CEZ:AV0Z40500505
Keywords : 19F MAS NMR * factor analysis * polymorphism
Subject RIV: CB - Analytical Chemistry, Separation
Impact factor: 3.350, year: 2011

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.
Permanent Link: http://hdl.handle.net/11104/0197244