HPLC法测定穿心莲注射液中穿心莲内酯的含量

Content determination of Andrographolide in Chuanxinlian Injection by HPLC

目的建立穿心莲注射液中穿心莲内酯的高效液相色谱法含量测定方法。方法采用高效液相色谱法测定含量,色谱柱:Agilent TC-C18柱(4.6 mm×150 mm,5μm);流动相:甲醇-水(50∶50);检测波长:224 nm;流速:1.0 ml/min。结果穿心莲内酯在0.02 022~0.1011 mg/ml(r=0.9999)内呈良好的线性关系,平均回收率(n=6)为99.1%(RSD=1.1%)。结论建立的测定穿心莲内酯的方法准确有效,有助于进一步完成穿心莲注射液的质量控制方法 。

Objective To establish the HPLC method for determination of Andrographolide content in Chuanxinlian In- jection.Methods HPLC was used in content determination,the chromatographic column was Agilent TC-C18 （4.6 mm× 150 ram,5 μm）,the mobile phase consisted of methanol-water （50：50）,the detection wavelength was 224 nm and the flow rate was 1.0 ml/min.Resuits The good linear relation was maintained when Andrographolide Was from 0.02 022 to 0.1011 mg/ml （r=0.9999）.The average recovery was 99.1% （n=6,RSD=1.1%）.Conclusion The method of determination of Andrographolide is accurate and effective,which can help to complete the quality control method of Andrographolide Injection.