integrating second-order calibration with analytical quality by design (aqbd) foruniversal calibration in pharmaceutical analysis

The quantitative determination of active pharmaceutical ingredients in complex matrices, such aspharmaceutical tablets from different manufacturers, poses challenges due to potential interferencefrom various molecules, some of which may be unknown [1]. to address this issue, we havedeveloped a novel and powerful approach by integrating second-order calibration with theanalytical quality by design (aqbd) framework for pharmaceutical analysis.our focus was on drug analysis using second-order data with the aqbd approach, where weleveraged second-order calibration methods such as rank annihilation factor analysis (rafa)and multivariate curve resolution-alternating least squares (mcr-als) using ph-wavelengthdata. the goal was to create a universal calibration model for the quantitation of acetylsalicylicacid (asa, aspirin) in different commercial formulations. by applying the aqbd approach andsecond-order calibration strategies, we successfully developed a calibration model with secondorder advantages. second-order data, obtained from spectrophotometric monitoring of complexmixtures of several drug formulations at different ph levels, provided unique insights andenhanced the selectivity, sensitivity, and robustness of the analytical method in the presence ofcomplex interfering matrices.this research highlights the effectiveness and novelty of integrating second-order calibrationwithin the aqbd framework for pharmaceutical analysis. our results demonstrate that secondorder calibration methods are powerful tools for developing universal calibration models, pavingthe way for more efficient and reliable [2] drug analysis in the pharmaceutical industry.