Maher Abdulrazzaq Al-hakeem , Lacramioara Popa , Cristina Dinu-Pirvu , Mihaela Violeta Ghica , Razvan Prisada

Abstract

Quality by design (QbD) framework focuses on identifying predetermined specifications where the constraints to the process and the material features of the products are critical. Implementing the QbD concept for the analytical method validation is the modern direction in the pharmaceutical industry This study's basic design involves applying analytical quality by design (AQbD) research phases in the authentication and application of the conventional approaches during the development of a dynamic principal composite design. The influential and predicted positive outcomes of developing the pragmatic AQbD method is an effective method to ensure that the method meets its designated requirements. The study aimed to develop a comprehensive stability-indicating approach of Levetiracetam using AQbD. This study has shown that the QbD approach allows different analytical parameters evaluation and measure. The proposed method for stability indication of Levetiracetam in tablets proved to be fast and straightforward, and the proposed methodology was valid for ruggedness, robustness, accuracy, specificity, and linearity‎.

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