In situ assessment of atorvastatin impurity using MALDI mass spectrometry imaging (MALDI-MSI)
Lívia Riberti Rodrigues1, Diogo Noin de Oliveira1, Mônica Siqueira Ferreira1
1INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil.
Abstract:
The analysis of impurities and degradation products in pharmaceutical preparations are usually performed by chromatographic techniques such as high-performance liquid chromatography (HPLC). This approach demands extensive analysis time, mostly due to extraction and separation phases. These steps must be carried out in samples in order to adapt them to the requirements of the analytical method of choice. In the present contribution, matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI-MSI) was employed to quantify an important degradation product in atorvastatin calcium 80 mg tablets: the atorvastatin lactone. Through the standard of the impurity, it was possible to perform quantitative analysis directly on the drug tablet, using a quick and novel approach, suitable for quality control processes in the pharmaceutical industry.
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