参苏口服液高效液相指纹图谱研究

Multi-component HPLC fingerprint chromatogram of Shensu oral liquid

目的建立参苏口服液的多成分HPLC指纹图谱。方法采用C18色谱柱(5μm,4.6 mm×250mm);柱温30℃;以乙腈-0.05%磷酸溶液为流动相,梯度洗脱;流速1.0 m L·min-1;检测波长283nm;分析时间60 min。结果在该色谱条件下可同时检测出参苏口服液中葛根素等13个共有色谱峰成分,方法学考察结果较好,10批次样品指纹图谱的相似度均>0.9。结论该方法简便、重复性好,为参苏口服液的整体质量评价提供了科学依据。

Objective To establish a multi-component HPLC fingerprint chromatogram of Shensu oral liquid. Methods The analysis of Shensu oral liquid diluent was developed on C18 column （5 μm, 4.6 mm X 250 mm） at 30 ℃ , with acetonitrile-0.05% phosphoric acid solution as the mobile phase with gradient elution, The flow rate was 1.0 L·min-1 and the detection wavelength was 283 nm, and the analytic time was 60 min. Results Under the chromatogram condition, puerarin and other constituents were determined, and 13 peaks were identified on the HPLC fingerprint. The methodological results were satisfactory. The similarity of the 10 batches of Shensu oral liquid was above 0.9. Conclusion The method is simple and highly reproducible, and can provide scientific basis for the quality control of Shensu oral liquid.