HPLC法测定六神丸中游离胆红素及总胆红素含量

HPLC Method for Determination of Free and Total Bilirubin in Liushen Pills

目的建立HPLC法测定六神丸中游离胆红素和总胆红素的含量。方法采用HPLC法,ODS-2色谱柱(250 mm×4.6 mm,5μm);以乙腈-1%冰醋酸水溶液(95∶5)为流动相;体积流量1 ml/min;检测波长450 nm;柱温30℃;进样量10μl。结果胆红素质量浓度在6.30~201.50μg/ml(r≥0.9991)范围内与峰面积线性关系良好;游离胆红素平均回收率为100.75%,RSD为2.25%,总胆红素平均回收率为106.66%,RSD为1.04%;六神丸中游离胆红素平均含量为0.072%,总胆红素平均含量为0.159%。结论建立HPLC法测定六神丸中游离胆红素限量检查及总胆红素的含量,此法简便快速准确,重复性好,可用于六神丸质量控制并指导临床用药。

Objective To establish an HPLC method for the determination of free bilirubin and total bilirubin in Liushen pills.Methods ODS-2(250 mm×4.6 mm,5μm)column,mobile phase acetonitrile-1%glacial acetic acid solution(95∶5).Volume flow rate is 1 ml/min;Detection wavelength:450 nm;Column temperature 30℃;The injection volume is 10μl.Results The concentration of bilirubin in the range of 6.30~201.50μg/ml(r≥0.9991)has a good linear relationship with the peak area.The average recovery of free bilirubin is 100.75%,RSD is 2.25%,the average recovery of total bilirubin is 106.66%,RSD is 1.04%.The average content of free bilirubin in Liushen pills is 0.072%,and the average content of total bilirubin is 0.159%.Conclusion To establish HPLC method for determination of free bilirubin and total bilirubin in Liushen pills.This method is simple,rapid,accurate and reproducible,and can be used for quality control and clinical application of Liushen pills.