NIR Imaging Spectroscopy for Quality Control of Pharmaceutical Drug Formulations

NIR Imaging Spectroscopy for Quality Control of Pharmaceutical Drug Formulations 

In the application discussed below, the derivation of quantitative results from NIR spectroscopic imaging data of solid drug formulations is reported. In order to assess the vaUdity of these procedures, however, the results will be compared to the compositional analysis of the same sample set by conservative NIR spectroscopic diffuse-reflection measurements with a single-element detector [68]. 

Quantitative Determination of Active Ingredients in a Pharmaceutical Drug Formulation 

From the total sample set (48 samples), 45 samples were used as calibration samples. The three samples excluded from the calibration set were selected on the basis of a representative variation of their active ingredient concentrations, and finally used as unknown test samples to predict the content of their active ingredients. Partial least squares (PLS) models for each active ingredient were developed with the Unscrambler Software (version 9.6 CAMO Software AS, Oslo, Norway) from the MSC-pretreated median spectra of all pixels of each of the 45 calibration sample images. Based on these calibration models, the predictions of the active ingredient content for each pixel of the imaging data of the three test samples and their evaluation as histograms, contour plots and RGB plots was performed with Matlab v. 7.0.4 software (see below). 

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