Abstract
Herein we present a novel approach for the quantification of active pharmaceutical ingredients (APIs) using mass spectrometry imaging. This strategy uses a filter paper previously “eluted” with a MALDI matrix solution as a support for analyte application. Samples are submitted to mass spectrometry imaging (MSI) and quantification through characteristic fingerprints is ultimately performed. Results for the content of rosuvastatin from a known formulation are comparable to those obtained with a validated HPLC method.
Highlights
Mass spectrometry (MS) has been increasingly employed as a powerful analytical tool that can be successfully implemented in pharmaceutical analyses[10] for its great specificity in providing reliable results regarding structure information of target molecules in complex mixtures
Rosuvastatin standard (Teva active pharmaceutical ingredients (APIs) India Limited, India) was diluted in the same solvent system, in different concentrations (0.12, 0.24, 0.36, 0.48 and 0.6 mg.mL−1, i.e. 25. 50, 75. 100 and 125%, respectively, as described in the previous subsection above) to build a calibration curve. 2 μL of the final sample solutions were spotted onto the filter paper strips, in triplicates, and sent for mass spectrometry analysis after solvent drying
The first was verified through characterization by tandem mass spectrometry (MS/MS; high-resolution figure with structure assignments can be found in supporting information)
Summary
Mass spectrometry (MS) has been increasingly employed as a powerful analytical tool that can be successfully implemented in pharmaceutical analyses[10] for its great specificity in providing reliable results regarding structure information of target molecules in complex mixtures. A concentrated rosuvastatin standard stock solution was employed for achieving all subsequent dilutions used in the calibration curve, made up with 98.5 mg of rosuvastatin (96.1% of purity) in 20 mL of methanol:acetonitrile (1:1), to achieve a final concentration of 4.733 mg.mL−1.
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