AAPS PharmSciTech

, Volume 14, Issue 2, pp 802–810 | Cite as

Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Research Article

Abstract

Botanical drug products have batch-to-batch quality variability due to botanical raw materials and the current manufacturing process. The rational evaluation and control of product quality consistency are essential to ensure the efficacy and safety. Chromatographic fingerprinting is an important and widely used tool to characterize the chemical composition of botanical drug products. Multivariate statistical analysis has showed its efficacy and applicability in the quality evaluation of many kinds of industrial products. In this paper, the combined use of multivariate statistical analysis and chromatographic fingerprinting is presented here to evaluate batch-to-batch quality consistency of botanical drug products. A typical botanical drug product in China, Shenmai injection, was selected as the example to demonstrate the feasibility of this approach. The high-performance liquid chromatographic fingerprint data of historical batches were collected from a traditional Chinese medicine manufacturing factory. Characteristic peaks were weighted by their variability among production batches. A principal component analysis model was established after outliers were modified or removed. Multivariate (Hotelling T 2 and DModX) control charts were finally successfully applied to evaluate the quality consistency. The results suggest useful applications for a combination of multivariate statistical analysis with chromatographic fingerprinting in batch-to-batch quality consistency evaluation for the manufacture of botanical drug products.

Key words

botanical drug products chromatographic fingerprint manufacturing process multivariate statistical analysis quality consistency 

Notes

Acknowledgments

This work was financially supported by the China International Science and Technology Cooperation Project (no. 2010DFB33630).

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Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  1. 1.Pharmaceutical Informatics Institute, College of Pharmaceutical SciencesZhejiang UniversityHangzhouChina
  2. 2.Office of Pharmaceutical Science, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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