In situ assessment of atorvastatin impurity using MALDI mass spectrometry imaging (MALDI-MSI)

Lívia Riberti Rodrigues; Diogo Noin de Oliveira; Mônica Siqueira Ferreira; Rodrigo Ramos Catharino

doi:10.1016/j.aca.2014.01.050

In situ assessment of atorvastatin impurity using MALDI mass spectrometry imaging (MALDI-MSI)

Anal Chim Acta. 2014 Mar 25:818:32-8. doi: 10.1016/j.aca.2014.01.050. Epub 2014 Feb 4.

Authors

Lívia Riberti Rodrigues¹, Diogo Noin de Oliveira², Mônica Siqueira Ferreira³, Rodrigo Ramos Catharino⁴

Affiliations

¹ INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: [email protected].
² INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: [email protected].
³ INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: [email protected].
⁴ INNOVARE Biomarkers Lab, Medicine and Experimental Surgery Department, School of Medical Sciences, University of Campinas, Campinas 13083-877, Brazil. Electronic address: [email protected].

PMID: 24626400
DOI: 10.1016/j.aca.2014.01.050

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.

Keywords: Atorvastatin; Impurities; Mass spectrometry imaging; Quality control.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Atorvastatin
Chemistry Techniques, Analytical / methods*
Chromatography, High Pressure Liquid
Heptanoic Acids / analysis*
Pyrroles / analysis*
Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization*
Tablets / chemistry
Temperature
Time Factors

Substances

Heptanoic Acids
Pyrroles
Tablets
Atorvastatin