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用于二甲双胍快速质量筛查的智能手机辅助薄层色谱法

Smartphone-Assisted Thin-Layer Chromatography for Rapid Quality Screening of Metformin.

作者信息

Bhattarai Ram Kumar, Pudasaini Sanam, Barstis Toni, Giri Basant

机构信息

Center for Analytical Sciences, Kathmandu Institute of Applied Sciences, Kathmandu, Nepal.

Department of Chemistry and Physics, Saint Mary's College, Notre Dame, Indiana, USA.

出版信息

Adv Pharmacol Pharm Sci. 2025 Jun 18;2025:3306550. doi: 10.1155/adpp/3306550. eCollection 2025.

Abstract

Type II diabetes remains a significant global public health issue, affecting both individual well-being and healthcare systems worldwide. Metformin hydrochloride is widely prescribed as the first-line treatment for managing diabetes. However, the increasing reports of substandard and falsified medicines, including metformin, circulating in the markets in recent years, highlights the urgent need for reliable and portable quality assurance tools. Thin-layer chromatography (TLC) has long been extensively used as a screening method to verify the identity and quality of various medicines. In this work, we present a smartphone-assisted TLC method for quantitative analysis of metformin hydrochloride. The TLC was performed using silica gel 60 F plates as the stationary phase and acetic acid-methanol-water 0.25:7:4 (v/v) as a mobile phase. We used a custom-made UV-illuminated TLC imaging box to capture images via smartphone and images were analyzed using a custom written smartphone application to calculate the and the concentration of metformin in the principal TLC spots. The smartphone application, , accurately calculated the values (0.604) consistent with those obtained using ImageJ software. The linearity of the method was 0.5-4 mg/mL. After optimization, the method was used to analyze metformin samples ( = 16) collected from local pharmacies. The results were compared with those from ImageJ analysis, UV-Vis spectrophotometry, and HPLC. The smartphone-based method identified 15 of the 16 samples as containing acceptable levels of metformin in accordance with pharmacopeial standards, consistent with ImageJ and spectrophotometric results. In contrast, the HPLC method indicated that all 16 samples met the pharmacopeial criteria.

摘要

2型糖尿病仍然是一个重大的全球公共卫生问题,影响着全世界个人的健康和医疗系统。盐酸二甲双胍作为治疗糖尿病的一线药物被广泛处方。然而,近年来市场上包括二甲双胍在内的不合格和假药报告不断增加,凸显了对可靠且便携的质量保证工具的迫切需求。薄层色谱法(TLC)长期以来一直被广泛用作验证各种药物身份和质量的筛选方法。在这项工作中,我们提出了一种用于盐酸二甲双胍定量分析的智能手机辅助TLC方法。TLC使用硅胶60 F板作为固定相,以0.25:7:4(v/v)的乙酸-甲醇-水作为流动相。我们使用定制的紫外线照射TLC成像盒通过智能手机捕获图像,并使用定制编写的智能手机应用程序分析图像,以计算主要TLC斑点中二甲双胍的比移值(Rf)和浓度。智能手机应用程序准确计算出的Rf值(0.604)与使用ImageJ软件获得的值一致。该方法的线性范围为0.5-4 mg/mL。优化后,该方法用于分析从当地药店收集的二甲双胍样品(n = 16)。将结果与ImageJ分析、紫外可见分光光度法和高效液相色谱法的结果进行比较。基于智能手机的方法根据药典标准确定16个样品中的15个含有可接受水平的二甲双胍,与ImageJ和分光光度法结果一致。相比之下,高效液相色谱法表明所有16个样品均符合药典标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d456/12197440/691772cac437/APS2025-3306550.001.jpg

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