HPLC法测定妇康乐颗粒中延胡索乙素的含量

Contents Determination of Tetrahydropalmatine in Fukangle Granules by HPLC

目的:建立妇康乐颗粒中延胡索乙素含量的高效液相色谱法。方法:选择Agilent 5 TC-C18色谱柱(250 mm×4.6 mm,5μm),流动相为0.6%冰醋酸溶液(三乙胺调整pH值为6.0)-乙腈,采用梯度洗脱,流速为1.0 mL/min,检测波长280 nm,柱温30℃,进样量为10μL。结果:延胡索乙素的进样浓度在6.052~96.837 mg/L(r=0.9999)呈良好线性关系;延胡索乙素的平均回收率为98.7%,RSD为2.7%(n=6);5个批次妇康乐颗粒样品中延胡索乙素的含量测定结果为0.0551 mg/g~0.1190 mg/g。结论:该方法可用于妇康乐颗粒中延胡索乙素的含量测定。

Objective:To establish a HPLC method for the contents determination of tetrahydropalmatine in fukangle granules.Methods:The HPLC analysis was performed on a Agilent 5 TC-C18(4.6 mm×250 mm,5μm)column.The mobile phase consisted of 0.6%glacial acetic acid solution(adjusting pH to 6.0 with triethylamine)and acetonitrile with a gradient elution at the flow rate of 1.0 mL/min,wavelength 280 nm,column temperature 30°C.The sample quantity was 10μL.Results:The contents of tetrahydropalmatine had good linear relationship in the ranges of 6.052-96.837 mg/L(r=0.9999).The average recoveries(n=6)were 98.1%with RSD of 2.7%.The contents in 5 sapmles of fukangle granules were 0.0551 mg/g-0.1190 mg/g for tetrahydropalmatine.Conclusion:According to the methodology validation,this method can be applied to the contents determination of tetrahydropalmatine in fukangle granules.