目的:建立同时测定复方益肾软胶囊中盐酸巴马汀、盐酸小檗碱和丹皮酚含量的方法.方法:采用反相高效液相色谱法.色谱柱为Diamonsil-C18(200 mm×4.6 mm,5μm),流速为1 mL·min-1,流动相为乙腈-0.03 mol·L-1磷酸二氢钾缓冲溶液(pH3.10,梯度洗脱),检测波长为265 nm,进样量为20μL.结果:盐酸巴马汀、盐酸小檗碱和丹皮酚进样量的线性范围分别为0.016 61～0.415 20 μg(r=0.999 9)、0.027 01～0.675 20 μg(r＝0.999 9)、0.157 00～1.255 70 μg(r=0.999 9);平均加样回收率分别为99.81%(RSD=0.82%,n=6)、99.53%(RSD=0.74%,n=6)、98.32%(RSD=0.87%,n=6).结论:本方法操作简便、准确、重复性好.可作为复方益肾软胶囊的质控方法.%OBJECTIVE: To establish a method for the content determination of palmatine hydrochloride, berberine hydrochloride and paeonolin in Compound yishen soft capsules. METHODS: RP-HPLC method was used. The determination was performed on Diamonsil-C18(200 mm ×4.6 mm, 5 μm)column with mobile phase consisted of acetonitrile-0.03 mol-L-1 potassium dihydrogen phosphate (pH 3.10, gradient elution) at a flow rate of 1 mL·min-1. The UV detection wavelength was 265 nm and injection volume was 20 μL. RESULTS: The linear ranges of berberine hydrochloride, palmatine hydrochloride and paeonolin were 0.016 61～0.415 20 μg(r=0.999 9),0.027 01～0.675 20 μg(r=0.999 9),0.157 00～1.255 70 μg(r=0.999 9),respectively. The average recoveries were 99.81％ (RSD=0.82％, n=6), 98.53％ (RSD=0.74％, n=6), 99.32％ (RSD=0.87％, n=6). CONCLUSION: The method is simple, accurate, and reproducible and can be used for the quality control of Compound yishen soft capsules.
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