Applications of near infrared spectroscopy technique for quality control of pharmaceutical ingredient blending

Abstract

The blending of Active Pharmaceutical ingredient (API) and more ingredients affects the uniformity and product quality. Near-infrared spectroscopy (NIRS) has become an interesting analytical technique to control the uniformity and product quality. This technique is a particularly more powerful method than high performance liquid chromatography (HPLC) for rapid and non-invasive analysis of powder blends. The objective of this study is to apply NIRS technique to control the quality of blend homogeneity. The NIR calibration model was performed by Partial Least Squares (PLS) model. The PLS calibration showed a strong correlation with the reference values and great accuracy were demonstrated, i.e., for API without lubricant set correlation coefficient (R²) = 0.9980, standard error of prediction (SEP) = 2.49, and for API with lubricant set R² = 0.9980 SEP = 2.24. The paired t-test at the 95% confidence level did not indicate any differences between the validation results by the NIRS and the method as specified in USP30 in powder blending process. From the experiment, the suitable mixing time of API and disintegrant were determined at 20 minutes and the mixing time of lubricant was not less than 3 minute after the homogeneity of API and disintegrant. The NIRS technique has potential to reduce the production time and cost in the future which have to be develop for on-line process control.