IDEAS home Printed from https://ideas.repec.org/a/etm/ijsrst/v11y2024i3id735.html

An Elaborative Review on Analytical (HPLC) Method Development and Quality by Design (Qbd) Approach

Author

Listed:
  • Trushali Mandhare
  • Uttam Singh Baghel

Abstract

Analytical method development is important in pharmaceutical industry as it ensures that the analytical assays used are accurate, precise, and reliable. It helps ensure that the safest compounds are used in drug development. Analytical method validation is required before a drug can be used for clinical trials. The current review details the need of departure from the pharmaceutical industry's Quality by Testing (QbT) prototype approach for quantifying chemical compounds to the Quality by Design (QbD) approach. QbD can be recommended strategy for analytical method development because it can, Improve method robustness which can help create more robust, reliable, and efficient analytical methods. This can lead to higher quality products and better patient safety. The QbD approach can help reduce the risk of method failure and out-of-specification (OOS) results. Also improve regulatory compliance.The QbD approach can help demonstrate a thorough understanding of methods and processes in pharmaceutical development.

Suggested Citation

  • Trushali Mandhare & Uttam Singh Baghel, 2024. "An Elaborative Review on Analytical (HPLC) Method Development and Quality by Design (Qbd) Approach," International Journal of Scientific Research in Science and Technology, Technoscience Academy, vol. 11(3), pages 998-1007, June.
    • Handle: RePEc:etm:ijsrst:v11:y2024:i3:id:735
    as

    Download full text from publisher

    File URL: https://ijsrst.com/home/article/view/IJSRST54310298
    File Function: Abstract page
    Download Restriction: no
    File URL: https://ijsrst.com/home/article/download/IJSRST54310298/IJSRST54310298
    File Function: Full text
    Download Restriction: no
    ---><---

    More about this item

    Keywords

    ;
    ;
    ;

    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:etm:ijsrst:v11:y2024:i3:id:735. 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.

    We have no bibliographic references for this item. You can help adding them by using 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: Pankaj Sharma (email available below). General contact details of provider: https://ijsrst.com/home .

    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.