Wang Shuangqin, Zhang Jingjing, Liu Juan, Qian Guangsheng, Fu Chunmei
West China School of Pharmacy, Sichuan University, Chengdu 610041, China.
J Pharm Anal. 2016 Aug;6(4):249-255. doi: 10.1016/j.jpha.2016.03.001. Epub 2016 Mar 15.
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.
为了进行质量控制,采用高效液相色谱-二极管阵列检测器(HPLC-DAD)建立了一种结合槐角丸(HP)色谱指纹图谱和同时测定其主要生物活性成分的方法。对于指纹图谱分析,选择16个峰作为特征峰,以评估从三个制造商不同批次收集的不同样品的相似度。17个槐角丸样品的相似度超过0.966,表明不同批次和制造商的样品在一定程度上是一致的。此外,对槐角丸中的七种生物活性标志物,即槐角苷、黄芩苷、柚皮苷、染料木素、芦丁、槲皮素和5-O-甲基维斯阿米醇苷进行了同时定量,以解释质量一致性。所提出方法的验证是可接受的,回收率测试的准确度为90.2%-106.9%。评估了该方法的日内和日间精密度,相对标准偏差(RSD)值小于2.81%。定量数据结果表明,六个标志物化合物(除5-O-甲基维斯阿米醇苷外)的含量在同一制造商生产的批次之间相当一致,而在不同制造商之间则有显著差异。所提出的方法有望发展成为一种用于槐角丸质量控制的有力工具。