Abstract/Summary

Poor quality medicines represent an expanding global public health threat facilitated by the Internet. A recent survey showed that one in five students have used modafinil to enhance learning ability mainly purchased from Internet sources. The aim of this work was to develop on-the-spot and simple methods for the quantification of modafinil in generic medicines using Fourier transform-infrared (FTIR), near-infrared (NIR) and Raman spectroscopy along with partial least square regression (PLSR). Modafinil tablets were measured in intact form using NIR and Raman and in powdered form using FTIR, NIR and Raman. Additionally, powder mixtures of crushed modafinil tablets and excipient(s) were prepared either by diluting the crushed tablets with excipient(s), or sequentially adding excipient(s) to the crushed tablets. Three PLSR models were constructed in MATLAB 2014a from powder mixtures and two from intact and powdered tablets. For FTIR and Raman spectroscopy, PLSR models based on tablets gave linear calibration curve with correlation coefficient (r2) values above 0.94 and a root mean square error of calibration (RMSEC) below 0.96% m/m. Conversely, the PLSR model based on powder sequential addition gave the highest accuracy using the NIR spectra (r2 = 0.99, RMSEC = 1.15% m/m). The latter model showed accuracy in predicting the concentration of the active pharmaceutical ingredient in modafinil generic medicines proving their authenticity. The overall results showed that the combination of the three spectroscopic methods with PLSR offered a rapid technique for authenticating generic modafinil medicines.