Implementing Quality by Design-A methodical approach in the RP-HPLC method development process
The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. The QbD based method development helps in generating a design space and operating space with knowledge of all method performance characteristics and limitations and successful method robustness within the operating space. A very useful component of QbD is the understanding of factors and their interaction effects by a desired set of experiments. For the purpose of QbD for HPLC methods, robustness and ruggedness should be verified early in the method development stage to ensure method performance over the lifetime of the product. Quality-by-Design principles are applied to build in a more scientific and risk-based multi-factorial approach to the development and validation of analytical methods using HPLC
Copyright (c) 2014 International Journal of Advances in Pharmaceutical Analysis
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
a) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
b)Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
c) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
After acceptance of the article, the author has to submit copyright form signed by all authors.