Counterfeit or just poor quality?

Counterfeit medicines are a major public health issue. The World Health Organisation suggests that the occurrence of counterfeits range from 1% in high income countries to as much as ~30-40% in low to middle income countries, however many of these may be substandard rather than counterfeit due to poor quality control. This research investigates the potential of Attenuated Total Reflectance Fourier Transform Infrared (ATR FTIR) techniques to provide rapid quantitative analysis of suspect tablet formulations. Sample preparation for ATR FTIR is minimal and only requires a single tablet to be ground to a fine powder prior to analysis. This enables more rapid analysis of tablets. Reference spectra of the active pharmaceutical ingredient (API) and excipients were recorded for identification purposes. Using atenolol as a model, quantitative data was obtained from calibrated mixtures of API and excipients. Tablets from various countries, India, Saudi Arabia, Nepal and UK were analysed using both ATR FTIR and reference UV analyses. Results demonstrated that the API was detectable down to ca 5% w/w of the tablet. Several examples of poor dosage quality control were identified.