Sakira Abdoul Karim, Ouattara Mitéhélé Sandrine Marie Josiane, Yabre Moussa, Bande Moumouni, Some Touridomon Issa
Laboratoire de Toxicologie, Environnement et Santé (LATES), Ecole Doctorale des Sciences de La Santé (ED2S), Université Joseph KI-ZERBO, 03 BP 7021 03, Ouagadougou, Burkina Faso.
J Anal Methods Chem. 2021 Oct 13;2021:4093859. doi: 10.1155/2021/4093859. eCollection 2021.
In substandard drugs enforcement, there is a need to develop reliable, fast, and inexpensive analytical methods. Due to its very characteristics, HPTLC offers opportunities for the development of methods that meet these requirements. This technique was used to develop and validate a method for the determination of sildenafil in pharmaceutical formulations from the licit and illicit supply chain in Burkina Faso. Taking into account optimization parameters such as measurement wavelength and mobile phase composition, the best elution quality is found at the maximum signals of spots on silica plates at 305 nm, using a mixture of dichloromethane-methanol mixture 9 : 1 (v/v) proportions. The method developed under these conditions was validated using the accuracy profile as a decision tool. The establishment of the response function curves allowed the choice of the polynomial function applied to the peak areas. This mathematical model provides a validity range between 0.4 and 0.6 mg/mL. The application of the developed and validated method to collected samples allowed the detection of two substandard drugs and confirmed the poor quality of drugs in the illicit market. More data using this approach in a variety of drug molecules could lead to the establishment of databases of counterfeit drugs in Burkina Faso.
在不合格药品执法中，需要开发可靠、快速且廉价的分析方法。由于其自身特性，高效薄层色谱法（HPTLC）为开发满足这些要求的方法提供了机会。该技术被用于开发和验证一种测定布基纳法索合法及非法供应链中药物制剂中西地那非含量的方法。考虑到诸如测量波长和流动相组成等优化参数，使用二氯甲烷 - 甲醇混合比例为9∶1（v/v）的混合物时，在硅胶板上305 nm处斑点的最大信号处可获得最佳洗脱质量。在这些条件下开发的方法使用准确度曲线作为决策工具进行了验证。响应函数曲线的建立允许选择应用于峰面积的多项式函数。该数学模型提供了0.4至0.6 mg/mL的有效范围。将开发并验证的方法应用于收集的样品，检测出两种不合格药品，并证实了非法市场上药品质量较差。使用这种方法对多种药物分子进行更多数据研究，可能会建立布基纳法索假药数据库。
