Multivariate control charts based on net analyte signal and near infrared spectroscopy for quality monitoring of Nimesulide in pharmaceutical formulations

Multivariate control charts based on the net analytical signal, in conjunction with near infrared spectroscopy, were developed to monitor the quality of a pharmaceutical formulation containing Nimesulide. Three control charts were developed: the NAS chart that corresponds to the analyte of interest (Nimesulide in this case), the interference chart that corresponds to the contribution of other compounds in the sample and the residual chart that corresponds to nonsystematic variation. From the limits estimated for each chart using samples inside the quality specifications, it was possible to identify the samples that were outside the specifications concerning Nimesulide concentration and to identify the presence of different constituents in the standard formulation.