QUANTITATIVE DETERMINATION OF API AND EXCIPIENTS IN LORAZEPAM TABLETS BY USING NIR-HYPERSPECTRAL IMAGE AND MCR-ALS.

Hyperspectral imaging (especially NIR Imaging) as an analytical tool in pharmaceutical research provides new opportunities to characterize tablets. Despite the promise of these techniques, there are still some aspects that need to be faced. The main one is the resolution and quantification of analytes at a low concentration in the tablet, particularly in some pharmaceutical formulations, such as antidepressants, where the concentration of Active Principal Ingredient (API) is in very low percentages. A key quality parameter for tablets is to ensure a homogeneous distribution of the API in the tablets. In this sense, the objective in this presentation is two-fold: to search for a methodology to accurately quantify low-content API formulations and to find procedures to evaluate/quantify the heterogeneity of the API distribution investigated on the surface of the tablet. With these aims, lorazepam tablets images were analyzed by using augmented Multivariate Curve Resolution (MCR). The obtained results were processed by domain statistics methodologies to asses the uniform distribution of lorazepam in the studied surface.