止咳宝片的HPLC指纹图谱研究

Study on the HPLC fingerprint chromatogram of Zhikebao Tablets

目的建立止咳宝片的高效液相色谱(high performance liquid chromatography,HPLC)指纹图谱,对止咳宝片的质量进行控制。方法用体积分数为50%的甲醇提取后,进行HPLC分析。色谱柱为Agilent ZORBAX SB-Phenyl(150 mm×4.6 mm,5μm),流动相为乙腈-4 mL·L^(-1)磷酸,梯度洗脱;流速为0.5 mL·min^(-1);检测波长为210 nm;柱温为30℃。结果20批样品HPLC指纹图谱相似度值为0.941~0.999,共标定了21个共有色谱峰,其中各指纹峰分离度较好;指认13个峰的特征药材归属,定性了8个峰。结论建立的方法简便高效,可为止咳宝片的质量控制奠定理论基础。

Objective To establish an HPLC fingerprint of Zhikebao Tablets for quality control.Methods After extraction with 50%volume fraction of methanol,the samples were subjected to HPLC analysis using an Agilent ZORBAX SB-Phenyl(150 mm×4.6 mm,5μm)chromatographic column.The mobile phase consisted of acetonitrile-4 mL·L^(-1)phosphoric acid,with a flow rate of 0.5 mL·min^(-1).Gradient elution was emplyed during the analysis.The detection wavelength was set at 210 nm,and the column temperature was 30℃.Results The HPLC standard fingerprints of Zhikebao Tablets were established and a total of 21 common chromatographic peaks were defined.The similarity range of 20 samples was 0.941-0.999.Conclusion The established HPLC fingerprint of Zhikebao Tablets was precise,reproducible,and stable,which can provide a theoretical basis for the quality control of Zhikebao Tablets.