HPLC法测定黄芪建中汤复方颗粒中两种成分的含量

Determination of two constituents in Huangqijianzhong Compound Granules by HPLC

目的:建立黄芪建中汤复方颗粒的质量控制方法。方法:采用HPLC双波长法同时测定制剂中芍药苷及肉桂酸的含量,色谱柱:依利特Hypersil ODS2 C_(18)柱(4.5mm×250mm,5μm);以乙腈为流动相A,以0.1%磷酸溶液为流动相B(0~24mim,A:10%;24~26mim,A:10%→24%;26~50min,A:24%),进行梯度洗脱;检测波长:0~39min,λ_1=248nm,39~50min,λ_2=285nm;流速为1mL/min;柱温:25℃。结果:芍药苷及肉桂酸分别在0.0414~0.4249mg/mL(r=0.9997)与0.0006~0.0056mg/mL(r=0.9996)范围内与峰面积呈良好线性关系;平均回收率分别为101.25%(RSD为2.18%)和96.01%(RSD为2.73%)。结论:所建方法专属性良好,精密度高,重复性好,可用于该颗粒的质量控制。

Objective：To establish the quality control method for Huangqijianzhong Compound granules. Methods：Content of pae- oniflorin and cinnamic acid in Huangqijianzhong compound granules were determinated by double wavelength HPLC. The Hypersil ODS2 C18 column（4.5mm× 250mm, Stem） was used with a mobile phase of acetonitrile（A）--0.1% phosphoric acid（B） in a gradient elution（0~24mim, A： 10% ;24~26mim, A.. 10%→24%; 26--50min, A： 24%） under the flow rate of lmL/min. The detection wavelength λ1 was 248nm in 0→39min and λ2 was 285nm in 39→50min. And the column temperature was 25℃. Results： Paeoni florin and cinnamic acid were linear in the range of 0.0414~0.4249mg/mL（r=0.9997） and 0.0006~0.0056mg/mL（r=0.9996） separately. The average recovery were respectively as 101.25% （RSD= 2. 18%） and 96.01% （RSD= 2. 80%）. Conclusion： The method has good specialization, precision degree and repeatability, and can be used for the quality control of Huangqijianzhong com- pound granules.