Fast detection and identification of counterfeit antimalarial tablets by Raman spectroscopy

Abstract

During the last decade there has been an apparent increase in the prevalence of counterfeit medicines in developing as well as developed countries. The pivotal antimalarial artesunate has been counterfeited on a large scale in SE Asia. In this work, the possibilities of Raman spectroscopy are explored as a fast and reliable screening method for the detection of counterfeit artesunate tablets. In this study, 50 'artesunate tablets', purchased in SE Asia, were examined. This spectroscopic method was able to distinguish between genuine and counterfeit artesunate and to identify the composition of the counterfeit tablets. These contained no detectable levels of artesunate, but consisted mostly of starch, calcite (CaCO 3 ), and paracetamol (4-acetamidophenol). In one particular case an admixture of rutile (TiO 2 ) and artesunate was detected. The results of the investigation by Raman spectroscopy were in agreement with those of colorimetric tests and of liquid chromatography-mass spectrometry on the artesunate. Moreover, principal components analysis (PCA) was combined with hierarchical cluster analysis to establish an automated approach for the discrimination between different groups of counterfeits and genuine artesunate tablets. These results demonstrate that Raman spectroscopy combined with multivariate analysis is a promising and reliable methodology for the fast characterization of genuine and counterfeit artesunate antimalarial tablets.

Reference database of Raman spectra of pharmaceutical excipients

“…[4 -6] Another domain is the production of pharmaceuticals where this technique can be used for process monitoring during the manufacturing of pharmaceuticals or as a quality control method. [7,8] Raman spectroscopy can also be used for the identification of counterfeit drugs, as has been shown by the identification of counterfeit antimalarial tablets [9] and Viagra  tablets. [10] The majority of the articles in pharmaceutical research focus on active ingredients but hardly pay any attention to the excipients present in these drugs.…”

“…presence of impurities) of excipients in counterfeits are often different from their corresponding authentic drugs. [9,10] Hence, as Raman spectroscopy allows fast (often in the range of seconds) and nondestructive spectra collection of drugs, it is an excellent tool for combating counterfeits.…”

Recent advances in linear and nonlinear Raman spectroscopy II

“…Therefore, a thermal micro-Raman spectroscopic study of the polymorphic transformation of famotidine under different compression pressures had been performed by Lin et al 201 From the same laboratory, a Raman investigation of the polymorphic conversion of this compound from form B to form A in the course of the milling process has been reported. 202 In a work, published by De Veij et al 203 the possible use of Raman spectroscopy is explored as a fast and reliable screening method for the detection of counterfeit artesunate tablets. The results of this study demonstrate that Raman spectroscopy combined with multivariate analysis is a promising and reliable methodology for the fast identification of genuine and counterfeit artesunate antimalarial tablets.…”

Determination of the composition of counterfeit Heptodin™ tablets by near infrared chemical imaging and classical least squares estimation

“…A series of analytical methodologies encompassing liquid chromatography [1][2][3], mass spectrometry (MS) [4], and vibrational spectroscopies, such as Raman [5,6], infrared (IR) [7] and near-infrared (NIR) have been used. NIR spectroscopy is a fast and non-destructive technique, with little or no sample preparation required.…”