目的：建立测试黄连素片中盐酸小檗碱含量的高效液相方法，并对此方法进行系统的方法学验证，以确保应用该方法测试的结果准确、可靠。方法：采用色谱柱：Agilent TC-C18柱（4.6 mm ×150 mm，5μm，Agilent，美国），流动相：乙腈－0.05 mol／L磷酸二氢钾溶液（45∶55，含5％的0.05 mol／L庚烷磺酸钠溶液），检测波长为265 nm。结果：盐酸小檗碱在2.5～80μg／mL范围内线性关系良好，得到线性回归方程为Y＝421.5X＋17.32，相关系数为0.9997（n＝6）；低、中、高浓度批内精密度的RSD值分别为0.30％、0.58％、0.30％，批间精密度的RSD为0.80％；重复性RSD为0.27％；低、中、高浓度的加样回收率分别为99.66％、99.88％、99.98％；供试品溶液室温放置8h稳定，RSD为0.41％。结论：本方法测定黄连素片中盐酸小檗碱的含量准确、可靠，操作简单、用时短，可用于黄连素片中盐酸小檗碱的含量测定。%Objective:To establish the HPLC method to determine content of berberine hydrochloride in Berberine Tablets,and to ensure the results are accurate and reliable by systematical testing methodology.Methods:The chromatographic column:Agilent TC-C1 8 column (4.6 ×1 50 mm,5 μm,Agilent,America),mobile phase:acetonitrile-0.05 mol/L potassium dihydrogen phosphate (0.05 mol/L sodium heptanesulfonate solution 45∶55,5%),the detection wavelength was 265nm.Results:The berberine hydro-chloride in 2.5ug·mL-1 -80ug·mL-1 linear relationship was good,and the linear regression equation was Y =421 .5X+1 7. 32,and correlation coefficient was 0.9997 (n =6);low,high concentration within batch precision values of RSD were 0.30%,0. 58%,0.30%,inter batch precision RSD was 0.80%;repeatability RSD was 0.27%;the low,recoveries,in high concentrations were 99.66%,99.88%,99.98%;the test solution was placed at room temperature for 8h,and RSD was 0.41%.Conclusion:This method for determination of berberine hydrochloride in tablet of berberine is accurate and reliable with simple operation and short time.It can be used for content determination of berberine hydrochloride in tablets of berberine.
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