Elżbieta U. Stolarczyk, Andrzej Kutner

Zastosowanie spektrometrii mas w analizie farmaceutycznej zanieczyszczeń organicznych

Application of mass spectrometry in pharmaceutical analysis of organic impurities - Pharmaceutical manufactures are responsible for the quality of their products. The quality assessment criteria concern identification, assay and impurity determination.
Impurity profile determination is often limited to the analysis of known or potential compounds (impurities which can be theoretically predicted). On the other hand, the analysis of unknown impurities is much more complicated and requires instrumental methods providing structural information. Therefore it is important to use new techniques solutions allowing to perform not only the detection, resolution and quantitative determination of studied compounds, but also structural elucidation and identification. Nowadays it has become possible due to the use of hyphenated techniques. Among those the most common in the analysis of organic impurities are chromatographic methods coupled with mass spectrometry (GC-MS, LC-MS). They allow direct analysis of even trace amount of compound in mixtures without the necessity of isolation, preparative purification or fractional enrichment. Additionally, as a result of chromatographic analysis important structural information can be obtained despite the similarities in structure between the impurity and the main compound.
The article presents theory and application of mass spectrometry in structural elucidation and identification of organic impurity. The usefulness of HPLC coupled with mass spectrometry was described.
Keywords: mass spectrometry, impurity, identification, structural elucidation, hyphenated techniques.