Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, IN 47907, USA.
J Pharm Biomed Anal. 2012 Jul;66:126-35. doi: 10.1016/j.jpba.2012.03.026. Epub 2012 Mar 24.
Counterfeit medicines have become a serious global problem. Consequently, analytical and pharmaceutical scientists have been active in developing and applying new methodologies to detect and analyze counterfeit medicines. Vibrational spectroscopy combined with chemometric methods is becoming a popular choice in this area of research. In this study, Raman microscopy was used to collect chemical images of counterfeit tadalafil tablets and multivariate curve resolution (MCR) was used to analyze the Raman spectra and reveal the identities of the excipients and active pharmaceutical ingredients (API) in each tablet. Resolved counterfeit tablet spectra were compared to the resolved genuine tablet spectra. Both similarities and dissimilarities were revealed by the analysis in terms of the identity of the excipients, the quantity of the API, and the distribution of the components. It was concluded that Raman microscopy combined with MCR is a powerful method to detect and analyze counterfeit tablets.
假冒药品已成为一个严重的全球性问题。因此，分析和制药科学家一直在积极开发和应用新方法来检测和分析假冒药品。振动光谱结合化学计量学方法在这一研究领域正成为一种流行的选择。在这项研究中，拉曼显微镜用于收集假冒他达拉非片剂的化学图像，多元曲线分辨（MCR）用于分析拉曼光谱并揭示每个片剂中赋形剂和活性药物成分（API）的身份。解析的假冒片剂光谱与解析的正品片剂光谱进行了比较。从赋形剂的身份、API 的数量以及成分的分布来看，分析揭示了相似之处和不同之处。结论是，拉曼显微镜结合 MCR 是一种检测和分析假冒片剂的强大方法。
