Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept

Abstract

Background: Xiaochaihu capsule is composed of seven traditional Chinese medicines. The pharmacopoeia only focuses on the quantitative detection of baicalin, which cannot fully reflect the quality of the preparation. Some medium polar components were used to establish the fingerprint of Xiaochaihu capsule, but there was no report on the strong polar components. Methods: A high performance liquid chromatography-corona charged aerosol detection technology was used to establish a fingerprint analysis method for Xiaochaihu capsules following an analytical quality by design approach. Definitive screening designed experiments were used to optimize the method parameters. A stepwise regression method was used to build quantitative models. The method operable design region was calculated using the experimental error simulation method. Plackett–Burman designed experiments were carried out to test robustness. Results: The contents of four components were simultaneously determined. There were seven common peaks in the fingerprint. The common peak area accounted for 91.72%. Both fingerprint and quantitative analysis methods were validated as applicable in the methodology study. The quantitative fingerprint analysis method for sugar components can fill the gap in the detection of strong polar components in the existing methods. It provides a new technology for the comprehensive overall evaluation of Xiaochaihu capsule.

Keywords

• quality by design
• Xiaochaihu capsule
• quantitative chromatographic fingerprint
• design space
• definitive screening design
• Plackett–Burman