Yabré Moussa, Sakira Abdoul Karim, Bandé Moumouni, Goumbri Bertrand W F, Ouattara Sandrine M, Fofana Souleymane, Somé Touridomon Issa
Higher Institute of Health Sciences (INSSA), Nazi BONI University, Bobo-Dioulasso, 01 P.O. Box 1091, Burkina Faso.
Laboratoire de Toxicologie Environnement et Santé (LATES), Joseph KI-ZERBO University, Ouagadougou, 03 P.O. Box 7021, Burkina Faso.
J Anal Methods Chem. 2022 May 3;2022:5335936. doi: 10.1155/2022/5335936. eCollection 2022.
Falsified drugs are of serious concern to public health worldwide, particularly for developing countries where quality control of drugs is inefficient. In law enforcement against such fake medicines, there is a need to develop reliable, fast, and inexpensive screening methods. In this work, the ability of an innovative low-cost handheld near-infrared spectrometer to identify falsifications among two antimalarial fixed dose combination tablets, dihydroartemisinin/piperaquine and sulfadoxine/pyrimethamine, has been investigated. Analyzed samples were collected in Burkina Faso mainly in rural transborder areas that could be infiltrated by illicit drugs. A principal component analysis was applied on the acquired near-infrared spectra to identify trends, similarities, and differences between collected samples. This allowed to detect some samples of dihydroartemisinin/piperaquine and sulfadoxine/pyrimethamine which seemed to be falsified. These suspicious samples were semiquantitatively analyzed by thin-layer chromatography using Minalab® kits. Obtained results allowed to confirm the falsifications since the suspected samples did not contain any of the expected active pharmaceutical ingredients. The capacity of the low-cost near-infrared device to identify specifically a brand name of dihydroartemisinin/piperaquine or sulfadoxine/pyrimethamine has been also studied using soft independent modelling of class analogy (SIMCA) in the classical and data driven versions. The built models allowed a clear brand identification with 100% of both sensitivity and specificity in the studied cases. All these results demonstrate the potential of these low-cost near-infrared spectrometers to be used as first line screening tools, particularly in resource limited laboratories, for the detection of falsified antimalarial drugs.
假药是全球公共卫生领域严重关切的问题，对于药品质量控制低效的发展中国家而言尤其如此。在打击此类假药的执法过程中，需要开发可靠、快速且廉价的筛查方法。在这项工作中，研究了一种创新型低成本手持式近红外光谱仪识别两种抗疟固定剂量复方片剂（双氢青蒿素/哌喹和磺胺多辛/乙胺嘧啶）中假药的能力。分析样本主要在布基纳法索的农村边境地区收集，这些地区可能会被非法药物渗透。对采集到的近红外光谱应用主成分分析，以识别所收集样本之间的趋势、相似性和差异。这使得能够检测出一些看似是假药的双氢青蒿素/哌喹和磺胺多辛/乙胺嘧啶样本。使用Minalab®试剂盒通过薄层色谱对这些可疑样本进行了半定量分析。获得的结果证实了这些假药，因为可疑样本中不包含任何预期的活性药物成分。还使用经典版和数据驱动版的类类比软独立建模（SIMCA）研究了低成本近红外设备特异性识别双氢青蒿素/哌喹或磺胺多辛/乙胺嘧啶品牌名称的能力。所建立的模型在研究案例中以100%的灵敏度和特异性实现了清晰的品牌识别。所有这些结果表明，这些低成本近红外光谱仪有潜力用作一线筛查工具，特别是在资源有限的实验室中，用于检测假药。
