Abstract

The overall control of the quality of botanical drugs starts from the botanical raw material, continues through preparation of the botanical drug substance and culminates with the botanical drug product. Chromatographic and spectroscopic fingerprinting has been widely used as a tool for the quality control of herbal/botanical medicines. However, discussions are still on-going on whether a single technique provides adequate information to control the quality of botanical drugs. In this study, high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC), capillary electrophoresis (CE) and near infrared spectroscopy (NIR) were used to generate fingerprints of different plant parts of Panax notoginseng. The power of these chromatographic and spectroscopic techniques to evaluate the identity of botanical raw materials were further compared and investigated in light of the capability to distinguishing different parts of Panax notoginseng. Principal component analysis (PCA) and clustering results showed that samples were classified better when UPLC- and HPLC-based fingerprints were employed, which suggested that UPLC- and HPLC-based fingerprinting are superior to CE- and NIR-based fingerprinting. The UPLC- and HPLC- based fingerprinting with PCA were able to correctly distinguish between samples sourced from rhizomes and main root. Using chemometrics and its ability to distinguish between different plant parts could be a powerful tool to help assure the identity and quality of the botanical raw materials and to support the safety and efficacy of the botanical drug products.

Highlights

  • In recent years, there has been increased interest in the United States in developing botanical preparations as pharmaceutical products and as dietary supplements

  • The ultra performance liquid chromatography (UPLC)- and high performance liquid chromatography (HPLC)- based fingerprinting with principal component analysis (PCA) were able to correctly distinguish between samples sourced from rhizomes and main root

  • We believe that use of chemometric techniques to analyze the spectra would provide a higher level of assurance that important characteristics are not overlooked, and provide consistency in the final botanical drug products

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Summary

Introduction

There has been increased interest in the United States in developing botanical preparations as pharmaceutical products and as dietary supplements. Near infrared spectroscopy [11] is a widely used technology in the pharmaceutical industry, which has advantages such as real-time measurement. These methods can be compared in order to determine their advantages and drawbacks and to provide assurance on how to obtain meaningful chromatographic fingerprints to identify the quality of botanical drug products. In combination with chemometric approaches, fingerprint technology can be applied as a powerful method for characterizing botanical drug of different origins and quality. Pattern recognition methods, such as principal component analysis (PCA), hierarchical cluster analysis(HCA), linear discriminant analysis (LDA), k-nearest neighbor (k-NN), soft independent modeling of class analogy(SIMCA), partial least squares-discrimination analysis (PLS-DA) are commonly applied for distinguishing different origins of botanical drugs

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