In-Line Vis-NIR Spectral Analysis for the Column Chromatographic Processes of the Ginkgo biloba L. Leaves. Part II: Batch-to-Batch Consistency Evaluation of the Elution Process

Abstract

An in-line monitoring method for the elution process of Ginkgo biloba L. leaves using visible and near-infrared spectroscopy in conjunction with multivariate statistical process control (MSPC) was established. Experiments, including normal operating batches and abnormal ones, were designed and carried out. The MSPC model for the elution process was developed and validated. The abnormalities were detected successfully by the control charts of principal component scores, Hotelling T2, or DModX (distance to the model). The results suggested that the established method can be used for the in-line monitoring and batch-to-batch consistency evaluation of the elution process.