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In situ Analysis of Oxytetracycline Tablets Based on MALDI-Mass Spectrometry Imaging.

RATIONALE
A thorough understanding of the content and distribution of active ingredients in pharmaceuticals is essential for drug efficacy and safety. Technological advancements in mass spectrometry imaging present an opportunity for methodological innovation by providing qualification and quantification analysis, as well as spatial information, in the same assay, which has great potential for applications in the rapid analysis and quality control of drugs.


METHODS
In this work, matrix-assisted laser desorption/ionization-mass spectrometry imaging (MALDI-MSI) was employed to directly analyze oxytetracycline tablets in order to map the active constituent distribution within the whole tablet. Quantitative analysis was capable of differentiating tablets containing various doses of the active pharmaceutical ingredient.


RESULTS
To establish the methodology, detailed factors that influence matrix spraying and spatial resolution during sample preparation and the data acquisition process were optimized systematically. Quantitative analysis could differentiate the tablets containing various doses of the active compound. The proposed method was successfully applied to analyze real commercial tablets.


CONCLUSIONS
The developed method could successfully achieve the spatial location of oxytetracycline in actual tablet samples. These results could contribute to pharmaceutical tracing technology, especially the formulation process of tablets, which is helpful for monitoring the quality of pharmaceutical products and guaranteeing drug security.