Characterization of Counterfeit Artesunate Antimalarial Tablets From Southeast Asia

Abstract

Abstract. In southeast Asia, the widespread high prevalence of counterfeits tablets of the vital antimalarial artesunate is of great public health concern. To assess the seriousness of this problem, we quantified the amount of active ingredient present in artesunate tablets by liquid chromatography coupled to mass spectrometry. This method, in conjunction with analysis of the packaging, classified tablets as genuine, substandard, or fake and validated results of the colorimetric Fast Red TR test. Eight (35%) of 23 fake artesunate samples contained the wrong active ingredients, which were identified as different erythromycins and paracetamol. Raman spectroscopy identified calcium carbonate as an excipient in 9 (39%) of 23 fake samples. Multivariate unsupervised pattern recognition results indicated two major clusters of artesunate counterfeits, those with counterfeit foil stickers and containing calcium carbonate, erythromycin, and paracetamol, and those with counterfeit holograms and containing starch but without evidence of erythromycin or paracetamol.

Counterfeit Medicines in Cambodia—Possible Causes

“…Logistic regression suggests that the counterfeit medicines were more likely to fail in the content analysis, similar to other reports (12,13). By putting some false or actual ingredients in fake drugs, counterfeiters may try to trick customers, as patients may think that they are getting better and recovering from their illness.…”

Analysis of illegally manufactured formulations of tadalafil (Cialis®) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy

“…This spectral signature includes not only the active pharmaceutical ingredient(s) but also the excipients. The analytical methods that provide most information on excipient composition are solid-state methods such as Raman spectroscopy [10,11,19], near infrared spectroscopy [4,5] or X-ray diffraction [7], whereas chromatography allows an accurate identification of active pharmaceutical ingredients but does not give information on excipients. DOSY NMR is thus a global method that permits to consider the drug preparation as a whole.…”

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.…”