HPLC法测定苦参康肤搽剂中苦参碱、氧化苦参碱和苍术素的含量

Simultaneous content determination of matrine,oxymatrine and atractylodin in Kushenkangfu liniment by HPLC

目的建立同时测定中药复方制剂苦参康肤搽剂中苦参碱、氧化苦参碱和苍术素的RP-HPLC方法,并对其进行质量控制。方法采用Inertsil C18(250 mm×4.6 mm,5μm)色谱柱,以甲醇:乙腈(体积比1∶3)-体积分数0.2%氨水为流动相进行梯度洗脱,流速为1.0 m L·min-1,检测波长为220nm,柱温为35℃。结果苦参碱、氧化苦参碱和苍术素三种成分的分离度均符合要求,线性范围分别为60.0-360 mg·L-1(r=0.999 0,n=6),10.0-60.0 mg·L-1(r=0.999 0,n=6),15.0-90.0mg·L-1(r=0.999 1,n=6),提取回收率为96.6%~105.1%。结论建立的HPLC方法可以为苦参康肤搽剂的质量评价方法提供依据。

Objective To establish the HPLC method for determination of matrine, oxymatrine and atractylodin in Kushenkangfu liniment and for the quality control of its products. Methods The separation was developed in a Kromasil C18 column（250 mm × 4. 6 mm,5 μm）by gradient elution with methanol- acetonitril（ V： V= 1：3） -0. 2% aqueous ammonia as a mobile phase,with the flow rate of 1.0 mL.min-1 The detection wavelength was 220 nm and the column temperature was 35 ℃. Results The liner ranges were 60. 0- 360 mg.L -1 （ r =0. 999 0,n =6） ,10. 0-60. 0 mg.L-1 （ r =0. 999 0,n =6） and 15.0- 90. 0 mg.L-1 （ r = 0. 999 1, n = 6 ）, The resolutions of oxymatrine, matrine and atractylodin meet the requirements, and the range of recovery was 96.6%- 105. 1%. Conclusions The method can provide the experimental basis to improve overall quality control of Kushenkangfu liniment