近赤外分光法による医薬品原料粉体の判別

Abstract

Near-infrared spectroscopy was employed in order to make a qualitative analysis of various pharmaceutical powders for the purpose of conducting a confirmation test for accepting raw pharmaceutical powders. The near-infrared spectrophotomater was used to determine the absorption spectra of powder, followed by the analysis of principal components of the spectra to calculate primary and secondary components, which are used as judgment criteria. A two-dimensional judgment model was also proposed. As a result it was shown that the near-infrared spectroscopy does not require pretreatment of powders and offers non-destructive and quick (about 1min) analysis of active ingredients in excipients. Consequently, a facilitated validation method of quality control for accepting raw powdery materials was proposed. It was then demonstrated that the excipients and major active ingredients were subjected to near-infrared spectroscopy for determining principal components, which satisfy the two-dimensional judgment model with a highaccuracy. Furthermore, comparative evaluation was made for the peaks appearing when the weighting factors of the principal components were subjected to loading plot as well as for chemical assignment derived from the absorption band at near-infrared region, which resulted in determination of the principal components to be judged.