ESTUDO DE PRÉFORMULAÇÃO E CARACTERIZAÇÃO TÉRMICA
DA ATORVASTATINA POR TÉCNICAS TÉRMICAS E FTIR
UTILIZANDO CORRELAÇÃO DE PEARSON
Atorvastatin, preformulation study, DSC, FTIR
Atorvastatin is an antilipemic drug from the statins’ group that has a great importance to
prevent cardiovascular disease and it is usually used as atorvastatin calcium. The aim of
this study was to characterize the atorvastatin and studying possible interactions with
different excipients by DSC and FTIR. DSC curves were obtained using a Shimadzu
calorimeter, model DSC-60, aluminum pan, under heating rate of 20 ºC min-1 at temperature
of 25-400 ºC. Consequently, curves were analyzed using TASYS software from Shimadzu.
The spectra of the samples were obtained on a spectrophotometer ATR-FTIR (IRPrestige-
21 Shimadzu), between 700 and 4000 cm-1, on average of 20 scans. We evaluated the
atorvastatin and binary mixtures’ spectral steadiness by making a linear correlation between
the theoretical spectra and the real ones obtained at room temperature (25 °C). The
theoretical spectra were obtained using an ad hoc algorithm. We evaluated by DSC that
there are chemical interactions with mannitol and sodium lauryl sulfate because there was
disappearance of the drug’s peak and appearance only of the excipients’ peaks. With
respect to the other excipients, there were only displacements of peaks suggesting physical
interactions, it means no incompatibility. From the FTIR evaluation using Person’s
correlation, it was not observed any physical interaction between atorvastatin and the
following excipients: starch glycolate, pregelatinized starch, croscarmellose, magnesium
stearate and lactose, since the value of r was between 0.8 and 1.0; in other words, it means
a good correlation. Moreover, it was confirmed a physical interaction with the sodium lauryl
sulfate. Finally, the results obtained by DSC were confirmed by FTIR data using the
Person’s correlation, so both analytical techniques demonstrated to be extremelly important
and effective tools for applying in a preformulation study.