目的 建立同时测定八味肾气丸中去氢土莫酸、茯苓酸、梓醇、桃叶珊瑚苷4个成分的高效液相色谱测定方法。方法 采用Hypersil C₁₈色谱柱(250 mm×4.6 mm,5 μm);流动相为乙腈-0.1%磷酸溶液,梯度洗脱;检测波长：0～18 min,241 nm(去氢土莫酸);18～50 min,210 nm(茯苓酸、梓醇和桃叶珊瑚苷);体积流量为1.0 mL/min;柱温25 ℃;进样量20 μL。结果 去氢土莫酸、茯苓酸、梓醇和桃叶珊瑚苷分别在3.35～67.00 μg/mL、3.50～70.00 μg/mL、3.07～61.40 μg/mL、3.25～65.00 μg/mL线性良好,r值均大于0.999 0,平均回收率分别为96.72%、97.87%、98.21%、98.09%,RSD值分别为1.08%、0.95%、0.64%、1.22%(n=6)。结论 该方法简便,结果准确,可用于八味肾气丸中去氢土莫酸、茯苓酸、梓醇、桃叶珊瑚苷的质量控制。

Objective To establish an HPLC method for simultaneous determination of dehydrotumulosic acid, pachymic acid, catalpol, and aucubin in Bawei Shenqi Pills. Methods The analysis was performed on Hypersil C₁₈ column (250 mm × 4.6 mm, 5 μm) with acetonitrile - 0.1% phosphoric acid solution as mobile phases for gradient elution. Detection with variable wavelength was used, and set at 241 nm for dehydrotumulosic acid, 210 nm for pachymic acid, catalpol, and aucubin. The flow rate was 1.0 mL/min. The column temperature was 25 ℃ with injection volume of 20 μL. Results The calibration curve was linear over the concentration range of 3.35 — 67.00 μg/mL for dehydrotumulosic acid, 3.50 — 70.00 μg/mL for pachymic acid, 3.07 — 61.40 μg/mL for catalpol, and 3.25 — 65.00 μg/mL for aucubin, respectively. The correlation coefficients of all curves were above 0.999 0. The average recoveries were 96.72%, 97.87%, 98.21%, and 98.09% with RSD 1.08%, 0.95%, 0.64%, and 1.22% (n=6), respectively. Conclusion The method is simple and accurate, which can be used in quantity control of dehydrotumulosic acid, pachymic acid, catalpol, and aucubin in Bawei Shenqi Pills.