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

Trushali Mandhare and Uttam Singh Baghel

International Journal of Scientific Research in Science and Technology, 2024, vol. 11, issue 3, 998-1007

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.

Keywords: RP-HPLC; method developement; Quality by Design (QbD) (search for similar items in EconPapers)
Date: 2024
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