Combinative method using HPLC fingerprint and quantitative analyses for quality consistency evaluation of an herbal medicinal preparation produced by different manufacturers

Abstract

A combinative method using HPLC-DAD fingerprint and quantitative analysis was developed and validated for manufacturer-to-manufacturer quality consistency evaluation of Yiqing preparations. For fingerprint analysis, 22 peaks were selected as the characteristic peaks to evaluate the similarities of different samples collected from different manufacturers. The similarities of 12 Yiqing samples were beyond 0.90, indicating that samples from different manufacturers were, to some extent, consistent. Additionally, simultaneous quantification of nine markers including berberine, aloe-emodin, rhein, emodin, chrysophanol, baicalin, baicalein, wogonoside, and wogonin in Yiqing was performed to interpret the quality consistency. The results from the quantitative data showed that the contents of these nine marker compounds were quite consistent for batches produced within one manufacturer and significantly different from manufacturer-to-manufacturer. This study demonstrated that a combination of the chromatographic fingerprint and quantitative analysis offers an efficient way to quality consistency evaluation of herbal preparation.