A simple protocol for the characterization of fraudulent erectile dysfunction medicines using ion beam analytical techniques

IF 4.9 2区 化学 Q1 CHEMISTRY, ANALYTICAL Microchemical Journal Pub Date : 2025-04-14 DOI:10.1016/j.microc.2025.113602
G.M. S. Souza , R. Debastiani , P. Chytry , M. Knebel , R. Thomaz , L. Amaral , J. F. Dias
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Abstract

In this work we developed a simple and fast protocol based solely on ion beam analytical techniques for the analysis of erectile dysfunction medicines containing sildenafil and vardenafil as active ingredients. To that end, RBS (Rutherford Backscattering Spectrometry), PIXE (Particle-Induced X-ray Emission) and MeV-SIMS (Secondary Ion Mass Spectrometry) were employed in the analysis of sildenafil citrate (Viagra®), vardenafil hydrochloride (Levitra®) and tadalafil (Cialis®) among other medications. The RBS and PIXE techniques provide information on the concentrations of major and trace elements present in the tablets respectively, while the MeV-SIMS technique was used for the determination of the molecular profile of the samples. The protocol is based on the detection of sulfur present in the tablets through the PIXE technique, while its validation relies on the detection of the active ingredients with the MeV-SIMS technique.
The results confirm that the protocol is quite suitable for the discrimination of different sildenafil- and vardenafil-based medicines. On the other hand, this protocol cannot be used for the study of tadalafil-based medicines since no detectable element by PIXE is present in its active ingredient.

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利用离子束分析技术表征勃起功能障碍假药的简单方案
在这项工作中,我们开发了一种简单快速的方案,仅基于离子束分析技术,用于分析含有西地那非和伐地那非作为活性成分的勃起功能障碍药物。为此,采用RBS(卢瑟福后向散射光谱法)、PIXE(粒子诱导x射线发射法)和MeV-SIMS(二次离子质谱法)对枸橼酸西地那非(伟哥®)、盐酸伐地那非(艾力达®)和他达拉非(西力士®)等药物进行分析。RBS和PIXE技术分别提供了片剂中主要元素和微量元素的浓度信息,而MeV-SIMS技术用于测定样品的分子谱。该方案基于通过PIXE技术检测片剂中存在的硫,而其验证依赖于使用MeV-SIMS技术检测活性成分。结果表明,该方案适用于以西地那非和伐地那非为主的不同药物的鉴别。另一方面,该方案不能用于以他达拉非为基础的药物的研究,因为其活性成分中不存在pxie可检测到的元素。
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来源期刊
Microchemical Journal
Microchemical Journal 化学-分析化学
CiteScore
8.70
自引率
8.30%
发文量
1131
审稿时长
1.9 months
期刊介绍: The Microchemical Journal is a peer reviewed journal devoted to all aspects and phases of analytical chemistry and chemical analysis. The Microchemical Journal publishes articles which are at the forefront of modern analytical chemistry and cover innovations in the techniques to the finest possible limits. This includes fundamental aspects, instrumentation, new developments, innovative and novel methods and applications including environmental and clinical field. Traditional classical analytical methods such as spectrophotometry and titrimetry as well as established instrumentation methods such as flame and graphite furnace atomic absorption spectrometry, gas chromatography, and modified glassy or carbon electrode electrochemical methods will be considered, provided they show significant improvements and novelty compared to the established methods.
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