通络外洗液有效成分二氢欧山芹醇当归酸酯的含量测定

Determination of the content of dihydroparsley angelic acid ester as an active ingredient in Tongluo External Lotion

目的探讨通络外洗液中二氢欧山芹醇当归酸酯的含量测定方法,以控制制剂的内在质量。方法采用高效液相色谱法(HPLC)测定通络外洗液中二氢欧山芹醇当归酸酯的含量,色谱洗脱柱为Kromasil 100-5-C18(4.6 mm×250 mm,5μm);流动相:乙腈-水(58∶42);流速:1 ml/min;检测波长:330 nm;柱温:35℃;进样量:5μl。结果二氢欧山芹醇当归酸酯在44.45~889.00μg/ml范围内具有良好的线性关系(r=0.9998);精密度、重复性、稳定性试验结果的相对标准偏差(RSD)均<2.00%,二氢欧山芹醇当归酸酯的回收率平均值为98.50%(RSD=1.79%,n=6),通络外洗液制剂中的二氢欧山芹醇当归酸酯含量不得低于0.20 mg/ml。结论采用HPLC测定通络外洗液有效成分二氢欧山芹醇当归酸酯的含量取得良好的质量测评效果。

Objective To study a method for the determination of dihydroparsin angelic acid ester in Tongluo External Lotion,so as to control the intrinsic quality of the preparation.Methods The content of dihydroparsin angelic acid ester in the washing solution was determined by high performance liquid chromatography(HPLC).The chromatographic elution column was Kromasil 100-5-C18(4.6 mm×250 mm,5μm);mobile phase:acetonitrile-water(58∶42);flow rate:1 ml per minute;detection wavelength:330 nm;column temperature:35℃;injection amount:5μl.Results Dihydroparsin angelic acid ester had a good linear relationship in the range of 44.45-889.00μg/ml(r=0.9998).The relative standard deviation(RSD)of precision,repeatability and stability test results were all<2.00%,the average recovery rate of dihydroparsin angelic acid ester as angelic acid ester was 98.50%(RSD=1.79%,n=6),and the content of dihydroparsin angelic acid ester in the Tongluo External Lotion preparation should not be less than 0.20 mg/ml.Conclusion HPLC is used to determine the content of dihydroparsin as an active ingredient in Tongluo External Lotion.