HPLC法测定肠宁舒颗粒中盐酸小蘖碱的含量

Control of Quality on Changningshu Granule

目的建立肠宁舒颗粒的质量控制方法。方法在SpherigelODSC18柱上,乙氰-0.05mol/L磷酸二氢钾溶液(31∶69)为流动相,检测波长为波长为345nm,流速为1.0ml/min测定盐酸小蘖碱的含量。结果盐酸小蘖碱的量在0.038～0.304μg范围内呈良好的线性关系(r=0.9999),回归方程为A=4281910C+3319。精密度试验RSD为0.55%,该方法平均回收率为98.72%,RSD=1.38%。结论该方法简单、快速、准确。

Objective To develop a method of quality control of Changningshu Granule.Methods Using Spherigel ODS C18 column, CH3CN-0.05mol/L KH2PO4(31∶69) as mobile phase, UV detector at wavelength 345nm.Results The Berberine hydrochloride curvers were linear between0.038～0.304μg(r = 0.9999), The mean recovery was 98.72%, and the RSD was 1.38%. Conclusion This method is simple, quick, and accurate.