RP-HPLC法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的含量

Simultaneous Determination of Palmatine Hydrochloride,Berberine Hydrochloride and Paeonolin in Compound Yishen Soft Capsules by RP-HPLC

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-C1(8200mm×4.6mm,5μm),流速为1mL.min-1,流动相为乙腈-0.03mol.L-1磷酸二氢钾缓冲溶液(pH3.10,梯度洗脱),检测波长为265nm,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0.01661～0.41520μg(r=0.9999)、0.02701～0.67520μg(r=0.9999)、0.15700～1.25570μg(r=0.9999);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.