title: In situ assessment of atorvastatin impurity using MALDI mass spectrometry imaging (MALDI-MSI).
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.
authors.affiliation: INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: liviariberti@gmail.com.
authors.forename: Lívia Riberti
authors.initials: LR
authors.lastname: Rodrigues
authors.affiliation: INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: diogo1986@gmail.com.
authors.forename: Diogo Noin
authors.initials: DN
authors.lastname: de Oliveira
authors.affiliation: INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: monicasiq@gmail.com.
authors.forename: Mônica Siqueira
authors.initials: MS
authors.lastname: Ferreira
authors.affiliation: INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: rrc@fcm.unicamp.br.
authors.forename: Rodrigo Ramos
authors.initials: RR
authors.lastname: Catharino
mesh_terms: D000069059:Atorvastatin; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D006538:Heptanoic Acids / Q000032:analysis*; D011758:Pyrroles / Q000032:analysis*; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; D013607:Tablets / Q000737:chemistry; D013696:Temperature; D013997:Time Factors
chemical_list: D006538:Heptanoic Acids; D011758:Pyrroles; D013607:Tablets; D000069059:Atorvastatin
keywords: Atorvastatin; Impurities; Mass spectrometry imaging; Quality control