Checking counterfeiting of pharmaceutical products by attenuated total reflection mid-infrared spectroscopy

Pharmaceutical products serve as the cornerstone of our healthcare system. Product quality is of paramount importance to safety and efficacy of the patients. The success of pharmaceuticals has led to attempts by dubious manufacturers to gain via counterfeiting of the products, while risking the lives of the billions of patients that depend on these products. As a result, there is critical need for an analytical tool that is simple to operate, is robust and lends itself to yielding a rapid fingerprint of a pharmaceutical. In this paper we suggest use of attenuated total reflection (ATR) mid-infrared spectroscopy as a tool for rapid fingerprinting of pharmaceuticals. Antibiotics have been used as a case study to demonstrate the utility of this approach. ATR mid-infrared spectra obtained from powdered solid pharmaceutical products were classified using multivariate data analysis. A partial least-squares discriminant analysis model was developed and tested using 57 pharmaceutical products (27 antibiotics). The model was able to predict antibiotic present in pharmaceutical formulation irrespective of brand or manufacturing process with a classification accuracy of 87.3%. This indicated that the model is robust with respect to variability in pharmaceutical formulations. In addition, the brand/manufacturing company of an antibiotic could be predicted by training a principal component analysis model for specific antibiotic to a classification accuracy of 90%. The results demonstrate the utility of the proposed approach, which can be used by the appropriate authorities for checking on counterfeiting of pharmaceutical products.