IDEAS home Printed from https://ideas.repec.org/a/plo/pone00/0198515.html
   My bibliography  Save this article

A novel quality by design approach for developing an HPLC method to analyze herbal extracts: A case study of sugar content analysis

Author

Listed:
  • Jingyuan Shao
  • Wen Cao
  • Haibin Qu
  • Jianyang Pan
  • Xingchu Gong

Abstract

The aim of this study was to present a novel analytical quality by design (AQbD) approach for developing an HPLC method to analyze herbal extracts. In this approach, critical method attributes (CMAs) and critical method parameters (CMPs) of the analytical method were determined using the same data collected from screening experiments. The HPLC-ELSD method for separation and quantification of sugars in Codonopsis Radix extract (CRE) samples and Astragali Radix extract (ARE) samples was developed as an example method with a novel AQbD approach. Potential CMAs and potential CMPs were found with Analytical Target Profile. After the screening experiments, the retention time of the D-glucose peak of CRE samples, the signal-to-noise ratio of the D-glucose peak of CRE samples, and retention time of the sucrose peak in ARE samples were considered CMAs. The initial and final composition of the mobile phase, flow rate, and column temperature were found to be CMPs using a standard partial regression coefficient method. The probability-based design space was calculated using a Monte-Carlo simulation method and verified by experiments. The optimized method was validated to be accurate and precise, and then it was applied in the analysis of CRE and ARE samples. The present AQbD approach is efficient and suitable for analysis objects with complex compositions.

Suggested Citation

  • Jingyuan Shao & Wen Cao & Haibin Qu & Jianyang Pan & Xingchu Gong, 2018. "A novel quality by design approach for developing an HPLC method to analyze herbal extracts: A case study of sugar content analysis," PLOS ONE, Public Library of Science, vol. 13(6), pages 1-15, June.
  • Handle: RePEc:plo:pone00:0198515
    DOI: 10.1371/journal.pone.0198515
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0198515
    Download Restriction: no

    File URL: https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0198515&type=printable
    Download Restriction: no

    File URL: https://libkey.io/10.1371/journal.pone.0198515?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Xingchu Gong & Yao Li & Huali Chen & Haibin Qu, 2015. "Design Space Development for the Extraction Process of Danhong Injection Using a Monte Carlo Simulation Method," PLOS ONE, Public Library of Science, vol. 10(5), pages 1-20, May.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Liangshan Ming & Zhe Li & Fei Wu & Ruofei Du & Yi Feng, 2017. "A two-step approach for fluidized bed granulation in pharmaceutical processing: Assessing different models for design and control," PLOS ONE, Public Library of Science, vol. 12(6), pages 1-25, June.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pone00:0198515. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosone (email available below). General contact details of provider: https://journals.plos.org/plosone/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.