Efficient Method Development on Pharmaceutical Impurities Based on Analytical Quality by Design

User Benefits

- Visualizing the resolution of API and impurities in the range of analysis conditions such as composition of mobile phase and column oven temperature comprehensively makes it efficient to find optimum analysis condition. - Visualizing the area of analysis condition that satisfies robustness through different lot of columns makes robustness evaluation efficient.

Introduction

Since pharmaceutical impurities requires strict control to ensure safety, development of highly reliable analysis methods is necessary. LabSolutions MD, a new Shimadzu software for method development, supports efficient method development based on Analytical Quality by Design (AQbD). AQbD-based analysis method development consists of the phases of initial screening, optimization, and robustness evaluation. This article introduces an example of its use in optimization and robustness evaluation of the column and mobile phase selected in the initial screening in order to realize high efficiency in the development of a robust LC method for impurities on ketoprofen. The resolution of each compound was evaluated by visualizing a "design space" after changing mobile phase composition, oven temperature and flow rate. In the step of robustness evaluation following optimization, resolution of each lot of columns was visualized and compared by design space to efficiently evaluate robustness among different lot of columns.

August 31, 2022 GMT