小儿清肺止咳片的HPLC指纹图谱研究

Fingerprint Analysis of XiaoEr QingFei ZhiKe Tablets by HPLC

目的采用高效液相色谱法(HPLC)建立小儿清肺止咳片的指纹图谱并进行分析。方法Agilent 1260高效液相色谱仪,色谱柱为Diamonsil-C_(18)柱(150 mm×4.6 mm,2.7μm);流动相为乙腈-0.1%磷酸水,梯度洗脱;流速为1.0 mL min^(-1);柱温为30℃;检测波长为280 nm;进样量为10μL。结果10批样品的指纹图谱具有18个共有峰,并指认出黄芩苷。10批样品相似度均在0.9500以上,各批样品一致性较好。通过聚类分析、主成分分析、正交偏最小二乘法-判别分析对10批次小儿清肺止咳片指纹图谱进行质量评价,可聚成4类,并发现黄岑苷等5个成分是造成不同批次样品差异性的主要标记物。结论该方法的精密度,稳定性和重复性测试结果良好,可用于控制小儿清肺止咳片的整体质量。

OBJECTIVE To establish and analysis the HPLC fingerprint of XiaoEr QingFei ZhiKe Tablets.METHODS Agilent 1260 high performance liquid chromatograph(HPLC)with Diamonsil-C_(18) column(150 mm×4.6 mm,2.7μm).The mobile phase was consisted of acetonitrile and 0.1%phosphoric acid solution as the mobile phase for gradient elution.The flow rate was 1.0 mL·min^(-1),a column temperature of 30℃and a detection wavelength of 280 nm.RESULTS The HPLC fingerprints of XiaoEr QingFei ZhiKe Tablets from 10 batches were established and eighteen common peaks were obtained,then one of them was identified as baicalin.The similarity degrees of these samples were over 0.9500.The 10 batches were divided into 4 groups through the pattern recognitions that was mostly caused bybaicalin.CONCLUSION The method has desirable precision,stability and repeatability,it can be used for the quality control of XiaoEr QingFei ZhiKe Tablets.