HPLC法测定颈复康颗粒中盐酸小檗碱的含量

Content Determination of Berberine Hydrochloride in Jingfukang Granules by HPLC

目的：建立测定颈复康颗粒中盐酸小檗碱含量的方法。方法：采用高效液相色谱法。色谱柱为Kromasil C18柱，流动相为乙腈-0．05mol／L磷酸二氢钾溶液（用磷酸调节pH至3．0，30：70，V／V），检测波长为350nm，流速为1．0ml／min，柱温为30℃，进样量为20μl。结果：盐酸小檗碱进样量在0．0244～0．488gg范围内与峰面积积分值呈良好的线性关系（r=0．9999）；精密度、稳定性、重复性试验的RSD≤1．33％；平均加样回收率为99．0％，RSD=0．57％（n=6）。结论：该方法简单、准确、重复性好，可用于颈复康颗粒的质量控制。

OBJECTIVE： To establish a method for the content determination of berberine hydrochloride in Jingfukang granules. METHODS ： HPLC method was adopted. The determination was performed on Kromasil C18 column with mobile phase consisted of acetonitrile-0.05 mol/L sodium hydrogen phosphate （pH value adjusted to 3.0 using phosphoric acid, 30 ： 70, V/V） at the flow rate of 1.0 ml/min. The detection wavelength was set at 350 nm, and the column temperature was 30 ℃. The injection volume was 20 μl. RESULTS： The linear range of berberine hydrochloride was 0.024 4-0.488 μg （r=0.999 9） with an average recovery of 99.0% （RSD=0.57%, n=6）. RSDs of precision, stability and reproducibility tests were lower than 1.33%. CONCLUSIONS： The method is simple, accurate and reproducible and can be used for the quality control of Jingfukang granules.