Near-infrared spectroscopic characterization of pharmaceutical powder blends.

Near-infrared (near-IR) spectroscopy was used to qualitatively assess the homogeneity of a typical direct compression pharmaceutical powder blend consisting of hydrochlorothiazide, fast-flo lactose, croscarmellose sodium, and magnesium stearate. Near-IR diffuse reflectance spectra were collected from thieved powder samples using a grating-based spectrometer. A second-derivative calculation and principal component analysis were performed on the spectra prior to qualitative evaluation. Blend homogeneity was determined using single- and multiple-sample bootstrap algorithms and traditional chi-square analysis. The results suggested that bootstrap techniques provided greater sensitivity for assessing blend homogeneity than chi-square calculations and that near-IR has great potential as an analytical tool in powder blend analysis.