Hanyi Xie1, Qichuan He1, Yanfang Zhao1, Huijuan Li1, Mei Zhao1, Xiangfeng Chen1, Zongwei Cai2, Kezhong Fang3, Hexing Song4. 1. Shandong Analysis and Test Centre, Qilu University of Technology (Shandong Academy of Sciences), Jinan, Shandong, P.R. China. 2. State Key Laboratory of Environmental and Biological Analysis, Department of Chemistry, Hong Kong Baptist University, Hong Kong, China. 3. Shandong New Time Pharmaceutical Co., Ltd, Lunan Pharmaceutical Group, Linyi, Shandong, P.R. China. 4. Intelligene Biosystems (QingDao) Co. Ltd., Qingdao, Shandong, P.R. China.
Abstract
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: Matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI-MSI) was employed to directly analyze oxytetracycline tablets in order to map the distribution of the active constituent 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.
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: Matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI-MSI) was employed to directly analyze oxytetracycline tablets in order to map the distribution of the active constituent 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.
Authors: Mariann Inga Van Meter; Salah M Khan; Brynne V Taulbee-Cotton; Nathan H Dimmitt; Nathan D Hubbard; Adam M Green; Gregory K Webster; Patrick A McVey Journal: Molecules Date: 2021-01-25 Impact factor: 4.411