Abstract
The aim of this study was to present a novel analytical quality by design (AQbD) approach for developing an HPLC method to analyze herbal extracts. In this approach, critical method attributes (CMAs) and critical method parameters (CMPs) of the analytical method were determined using the same data collected from screening experiments. The HPLC-ELSD method for separation and quantification of sugars in Codonopsis Radix extract (CRE) samples and Astragali Radix extract (ARE) samples was developed as an example method with a novel AQbD approach. Potential CMAs and potential CMPs were found with Analytical Target Profile. After the screening experiments, the retention time of the D-glucose peak of CRE samples, the signal-to-noise ratio of the D-glucose peak of CRE samples, and retention time of the sucrose peak in ARE samples were considered CMAs. The initial and final composition of the mobile phase, flow rate, and column temperature were found to be CMPs using a standard partial regression coefficient method. The probability-based design space was calculated using a Monte-Carlo simulation method and verified by experiments. The optimized method was validated to be accurate and precise, and then it was applied in the analysis of CRE and ARE samples. The present AQbD approach is efficient and suitable for analysis objects with complex compositions.
Highlights
The concept of quality by design (QbD) has been increasingly applied to the development and optimization of analytical methods, which is known as analytical quality by design (AQbD)
Differed from the conventional AQbD approach described in the introduction section, critical method attributes (CMAs) and critical method parameters (CMPs) were determined in sequence with a same data set in the novel AQbD approach
If these experiments were used for CMP selection, CMAs and CMPs can be determined using a same set of experimental data, which will be very efficient
Summary
The concept of quality by design (QbD) has been increasingly applied to the development and optimization of analytical methods, which is known as analytical quality by design (AQbD). Many analytical methods were developed following an AQbD approach, such as the capillary electrophoresis method[1], Karl Fischer titration methodology[2], the supercritical fluid chromatography method[3] and so on. A novel AQbD approach and its application to sugar content analysis for herbal extracts funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
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