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ANALYSIS OF DRUG RELATED IMPURITIES BY INFRARED SPECTROMETRY IN THE CLASS OF STATINS

SZILÁRD ZSOLT FARKAS, SILVIA IMRE^*, DANIELA-LUCIA MUNTEAN, AMELIA TERO-VESCAN

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The aim of this study was to determine the applicability of IR spectrometry in the study of drug-related impurities, method which is usually applied as an identification method. We intended to determine the extent to which an impurity of the drug-substance can be detected by IR spectra interpretation and by other possibilities offered by the software used for data processing. Also by choosing proper impurities, impurity A for simvastatin and impurity H for atorvastatin, we aimed to develop a rapid method suitable for stability studies. In order to determine the limit of an impurity detectable by FTIR, mixtures with different concentrations of the drug substance and impurity were analyzed. Confirmation of the exact concentration of the impurity in samples was carried out by high performance liquid chromatography with UV detection.