Application of thermal analysis and pyrolysis coupled to GC/MS in the qualification of simvastatin pharmaceutical raw material

摘要

The simvastatin (SV) is nowadays produced semi-synthetically from lovastatin. It’s one of the statins most commonly used to treat several forms of hypercholesterolemia. This study aimed to apply the thermal characterization of the SV raw material using thermoanalytical techniques and its degradation products by Pyrolysis coupled to Gas chromatography/Mass spectrometry (Pyr-GC/MS). It was studied three samples of SV (SVA, SVB, and SVC). The results showed thermal behavior differences of the samples during the melting process transition and the activation energies (E _a) of the thermal decomposition, which were correlated to the thermal stability of them. The first decomposition step of Pyr-GC/MS showed two new compounds of m/z 284 and 207, in proportions dependents according to the pyrolysis temperature.