Quality evaluation of Huaijiao pill by chromatographic fingerprint and simultaneous determination of its major bioactive components.

For quality control purpose, an approach of combining chromatographic fingerprint of Huaijiao pill (HP) and simultaneous determination of its major bioactive components was developed using high performance liquid chromatography coupled with diode array detector (HPLC--DAD). For fingerprint analysis, 16 peaks were selected as the characteristic peaks to evaluate the similarities of different samples collected from different batches of three manufacturers. The similarities of 17 Huaijiao pill samples were beyond 0.966, indicating that samples from different batches and manufacturers were, to some extent, consistent. Additionally, simultaneous quantification of seven bioactive markers, namely sophoricoside, baicalin, naringin, genistein, rutin, quercetin and 5-O-methylvisammioside, in HP was performed to interpret the quality consistency. The validation of the proposed approach was acceptable, with the accuracy of 90.2%-106.9% in recovery test. The intra-day and inter-day precisions of the method were evaluated and the RSD values were less than 2.81%. The results from the quantitative data showed that the contents of six marker compounds (except for 5-O-methylvisammioside) were quite consistent between batches produced by one manufacturer and significantly distinctive among different manufacturers. The proposed approach was expected to be developed as a powerful tool for the quality control of HP.