Development of a Calibration Model to Determine Drug Concentration in Pharmaceutical Mixtures

A robust calibration model was created using Near Infrared Spectroscopy (NIR) and by minimizing the correlation between the active pharmaceutical ingredient (API) and components in a pharmaceutical process. An experimental model was used to minimize correlation and create a calibration model to detect API in a mixture. A design of experiment (DoE) was prepared using six components. A total of nine placebos were prepared using different concentrations of each component.;A series of mixtures were prepared using placebo, granulation and API or using placebo and API. The correlation between components when using granulation, placebo and API was of 99% because concentrations followed a pattern: if API concentration increased, components concentrations decreased. To break that pattern and to decrease the high correlation, only placebo and API were used and the concentrations of the components were modified.;With the new approach, if the concentration of API increases, not all of the concentrations of the components will decrease. A more robust model was then created because of the change in correlation.;The predictions obtained from the calibration model show a very robust model which was achieved by reducing the high correlation presented originally.