Chemometrical analysis of fingerprints for the detection of counterfeit and falsified medicines

Abstract Counterfeit medicines pose a major threat to public health worldwide. These pharmaceuticals are mostly manufactured without respecting Good Manufacturing Practices. Moreover, they are not subjected to any form of quality control, and therefore their safety, efficacy, and quality cannot be guaranteed. Extensive research on counterfeit medicines has already been performed and published in literature. This review aims at providing an updated overview of the use of fingerprints and subsequent multivariate (chemometrical) data analysis in the field of counterfeit medicine detection. Fingerprinting could be a useful tool in the analysis of counterfeit medicines because it generates a holistic view of a sample, rather than focusing on specific and predefined characteristics, such as identification and quantification of present active pharmaceutical ingredients. This review first provides an introduction into the counterfeiting problem. Next, the concept of fingerprinting and the basic principles of chemometrics are explained, followed by a description of the successful application of fingerprints in the field of Pharmacognosy. The last part of this review provides an overview describing the use of fingerprints in counterfeit medicine research.