Development and Validation of HPLC method by using QbD approach of Anastrozole

In a nutshell, the current study demonstrated the successful use of QbD principles to develop an HPLC method for Anastrozole with improved robustness and performance. The highly influential factors were identified and then optimized based on the initial prioritization and factor screening studies to improve the method's robustness. The response surface mapping was especially useful in improving understanding of the factor-response relationship and the interactions that go with it. Extensive validation studies ensured the method's robustness, even with extreme variations in key variables affecting performance. Furthermore, the method demonstrated significantly higher sensitivity for Anastrozole than previously reported in the literature. A simple, rapid, sensitive, and economically stable analytical method for quantifying Anastrozole has been successfully developed using the systematic QbD-based approach. Risk assessment studies were used to help prioritize the factors that had a significant impact on the method parameters.