Analytical quality-by-design (AQbD) approach for comprehensive analysis of bioactive compounds from Citrus peel wastes by UPLC

Vol 14 NO. 2 (2024)

“…The design of experiments (DoE) was applied to identify the significant effect of variables such as critical method parameters (CMPs) and critical process parameters (CPPs) on critical analytical attributes (CAAs) and critical quality attributes (CQA) of the extracted product. The established acceptance criteria and requirements of all the validation parameters were defined as the CAAs and the physicalchemical properties, such as a high-quality and purity of the dried extracted product (the purity ≥90%; total residual solvent <5000 ppm) were defined as the CQAs [28,31,[33][34].…”

“…The method operable region and continuous improvement process provide robust analytics with regulatory flexibility. The experiments were conducted in N-runs according to the Placket-Burman design (k<N−1; where, K -the number of variables and N -the number of experiments) [28,[30][31][32][33][34]. The concentration of UA/ OA/BA (Cs), mg/mL as a yield of extraction and the SST parameters -the column efficiency (theoretical plates -N), the tailing factor (USP symmetry -the coefficient of the peak symmetry S=W0.05/2f), the resolution (Rs) were used as responses or the dependent variables.…”

Ultrasound-Assisted Extraction- and Liquid Chromatography-Based Method Development and Validation for Obtaining and Qualitative Determination of Apple Pomace Three Triterpene Acids using Analytical Quality by Design

“…The design of experiments (DoE) was applied to identify the significant effect of variables such as critical method parameters (CMPs) and critical process parameters (CPPs) on critical analytical attributes (CAAs) and critical quality attributes (CQA) of the extracted product. The established acceptance criteria and requirements of all the validation parameters were defined as the CAAs and the physicalchemical properties, such as a high-quality and purity of the dried extracted product (the purity ≥90%; total residual solvent <5000 ppm) were defined as the CQAs [28,31,[33][34].…”

“…The method operable region and continuous improvement process provide robust analytics with regulatory flexibility. The experiments were conducted in N-runs according to the Placket-Burman design (k<N−1; where, K -the number of variables and N -the number of experiments) [28,[30][31][32][33][34]. The concentration of UA/ OA/BA (Cs), mg/mL as a yield of extraction and the SST parameters -the column efficiency (theoretical plates -N), the tailing factor (USP symmetry -the coefficient of the peak symmetry S=W0.05/2f), the resolution (Rs) were used as responses or the dependent variables.…”