HPLC法测定朱砂安神丸中盐酸小檗碱含量

Determination of Berberine Hydrochloride in Zhusha Anshen Wan by HPLC

目的:采用高效液相色谱法测定朱砂安神丸中盐酸小檗碱的含量,增加朱砂安神丸的质量控制指标。方法:以Phenomenex C_(18)(250mm×4.6mm,5μm)为色谱柱;以乙腈-0.05mol/L磷酸二氢钾溶液(50∶50)(每100mL中加十二烷基硫酸钠0.4g,再以磷酸调节pH=4.0)为流动相;流速为1.0 mL/min,检测波长为264nm,柱温30℃。结果:盐酸小檗碱在10.09~161.47μg/mL之间呈良好线性关系;平均加样回收率为98.01%,RSD为1.04%。结论:该方法稳定可行,可作为企业内部标准进一步控制保证制剂的质量与安全。

Objective ： To accurately determine the Berberine hydrochloride content in Zhusha Anshen Wan by HPLC for increasing the quality control index. Methods ： The HPLC analysis was carried out in Phenomenex C18 （250mm×4.6mm, 5μm） with a mohile phase of acetonitrile--0.05mol/L KH2PO4 （50 ： 50） （add 0.4g of lauryl sodium sulfate per 100mL, using phosphoric acid to adjust pH4.0）. Flow rate was 1. 0mL/min, detection wavelength was 264 nm and column temperature was 30℃. Results： Berberine hydrochloride had good linear relationship between 10.09 and 161.47μg/mL. The average recovery rate was 98.01%, RSD was 1.04 %. Conclusion ： The method is stable and feasible, and can be used as internal standard to ensure the preparations secure and effective.