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An LDI-MSI approach for targeted and untargeted differentiation and assessment of pharmaceutical formulations

DOI:10.1016/j.talanta.2018.12.044 期刊:Talanta 出版年份:2019 更新时间:2025-09-23 15:23:52
摘要: Falsified, counterfeit and adulterated medicines are an endemic problem worldwide that results in both monetary and health-related losses. Developing fast and reliable methods that are able to present a timely result based on the drug’s spectral profile is an effort that is sure to benefit those involved in the whole distribution chain. We propose herein a Laser Desorption/Ionization imaging-based method that provides simple and minimal sample preparation; this method is capable of providing specific markers that characterize adulterations, using as proof of concept one of the most adulterated drug products for oral use, sildenafil. Our approach is able to provide quality markers, which can be applied in the fast screening of any product within the same molecular class. This same strategy may be a useful alternative to provide accurate measurements with high specificity for unraveling contaminants and/or byproducts in virtually any given pharmaceutical product.
作者: Luís Fernando Godoy Falco,Carlos Fernando Odir Rodrigues Melo,Diogo Noin de Oliveira,Tatiane Melina Guerreiro,Rodrigo Ramos Catharino
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Developing a fast and reliable method using Laser Desorption/Ionization-Mass Spectrometry Imaging (LDI-MSI) for targeted and untargeted differentiation and assessment of pharmaceutical formulations, specifically to identify falsified and adulterated medicines, with sildenafil citrate as a proof of concept.

The LDI-MSI approach combined with multivariate analysis effectively differentiates pharmaceutical formulations, providing specific markers for fast screening of falsified medicines. It offers high sensitivity and specificity with minimal sample preparation, making it suitable for forensic and quality control applications.

The method may have limitations in absolute quantification due to signal intensity variations and potential ion suppression. It relies on specific equipment and software, which may not be universally available. The approach is demonstrated on sildenafil and may require validation for other APIs.

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