QbD Approach to Hplc Method Development and Validation of the Simultaneous Estimation of Sulbactum and Durlobactum in Pharmaceutical Dosage Form

Abstract

The pharmaceutical industry consistently emphasizes the importance of product quality, safety, and efficacy. To enhance these aspects, scientific tools such as Quality by Design (QbD) and Process Analytical Technology (PAT) have been widely implemented. These approaches provide a systematic and science-based framework for pharmaceutical development and manufacturing, aiming to improve product understanding, process control, and ultimately, minimize risks while maximizing productivity and quality.
The QbD framework, initially developed for manufacturing processes, has been successfully extended to the field of analytical method development—a concept now termed Analytical Quality by Design (AQbD). AQbD applies the principles of QbD to ensure that analytical methods are not only fit for their intended purpose but also robust and reliable throughout the product lifecycle.
Regulatory bodies, including the U.S. FDA, have recognized the importance of QbD and released guidance documents specifically for its implementation in immediate-release and extended-release formulations. Moreover, the International Council for Harmonisation (ICH) encourages the application of QbD principles through its guidelines Q8 to Q11, supporting its adoption in both formulation and analytical development.