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Article

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

1
Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China
2
College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
3
State Key Laboratory of Component-Based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
*
Author to whom correspondence should be addressed.
Separations 2022, 9(11), 378; https://doi.org/10.3390/separations9110378
Submission received: 15 August 2022 / Revised: 8 November 2022 / Accepted: 9 November 2022 / Published: 18 November 2022

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.
Keywords: Vis-NIR spectroscopy; Ginkgo biloba L. leaves; in-line analysis; column chromatographic elution; consistency evaluation; multivariate statistical process control (MSPC) Vis-NIR spectroscopy; Ginkgo biloba L. leaves; in-line analysis; column chromatographic elution; consistency evaluation; multivariate statistical process control (MSPC)

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MDPI and ACS Style

Li, W.; Wang, X.; Chen, H.; Yan, X.; Qu, H. 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. Separations 2022, 9, 378. https://doi.org/10.3390/separations9110378

AMA Style

Li W, Wang X, Chen H, Yan X, Qu H. 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. Separations. 2022; 9(11):378. https://doi.org/10.3390/separations9110378

Chicago/Turabian Style

Li, Wenlong, Xi Wang, Houliu Chen, Xu Yan, and Haibin Qu. 2022. "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" Separations 9, no. 11: 378. https://doi.org/10.3390/separations9110378

APA Style

Li, W., Wang, X., Chen, H., Yan, X., & Qu, H. (2022). 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. Separations, 9(11), 378. https://doi.org/10.3390/separations9110378

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