HPLC法测定肾康灵胶囊中盐酸小檗碱的含量

Determination of Berberine Hydrochloride in ShenKangLing Capsules by HPLC

目的 建立肾康灵胶囊中盐酸小檗碱的HPLC含量测定方法,为质量控制提供依据。方法 采用HPLC法,色谱柱:Sapphire-C_(18)柱(4.6×250 mm, 5μm);流动相:乙腈-0.1%磷酸溶液(梯度洗脱);流动相流速:1.0 mL·min^(-1);检测波长:265 nm;柱温:30℃,进样量:10μL。结果 盐酸小檗碱含量在0.0584~0.5840μg范围内与峰面积值呈良好线性关系(R^(2)=0.9981),精密度和重复性试验的RSD均<2.0%(n=6),稳定性试验(18 h内)的RSD为1.11%,平均加样回收率为98.24%,RSD=1.43%(n=6)。结论 该方法快速简便、稳定性好,专属性强,重复性良好,可为肾康灵胶囊的质量控制提供依据。

OBJECTIVE To establish the HPLC method for determinating the content of berberine hydrochloride in ShenKangLing capsules,so as to provide a basis for quality control of ShenKangLing capsules.METHODS HPLC method was adopted.The determination was performed on a Sapphire-C_(18) column(4.6×250 mm,5μm)with a mobile phase consisted of acetonitrile-0.1%phosphoric acid solution(gradient elution)at a detection wavelength of 265 nm and a flow rate of 1.0 mL·min^(-1).The sample size was 10μL.RESULTS The content of berberine hydrochloride from 0.0584 to 0.5840μg showed a good linear relationship with peak area value(R^(2)=0.9981),RSD for precision and repeatability test was<2.0%(n=6),RSD for stability test(within 18 hours)was 1.11%,average sample recovery was 98.24%,and RSD=1.43%(n=6).CONCLUSION This method is simple,accurate,strong exclusivity,good stability and reproducibility,which can provides a reference for the quality control of ShenKangLing capsules.