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目的:建立风痛安胶囊(防己、通草、木瓜、黄柏等)中粉防己碱、防己诺林碱及盐酸小檗碱含量的同时测定方法。方法:采用高效液相色谱法。色谱柱为Phenomenex Gemini C18(4.6mm×250mm,5μm)柱;流动相:甲醇-乙腈-磷酸盐缓冲液(0.01mol/L磷酸二氢钾和0.01mol/L庚烷磺酸钠等量混合,含0.2%三乙胺并用磷酸调pH值至3.0)(25∶20∶55);检测波长为230nm。结果:粉防己碱进样量在0.05152~0.8243μg范围内与峰面积呈良好的线性关系,r=0.9999,平均回收率为97.23%,RSD为1.3%(n=9);防己诺林碱在0.03520~0.5632μg范围内与峰面积呈良好的线性关系,r=0.9999,平均回收率为99.56%,RSD为1.6%(n=9);盐酸小檗碱进样量在0.03136~0.5018μg范围内与峰面积呈良好的线性关系,r=0.9997,平均回收率为98.22%,RSD为1.5%(n=9)。结论:本方法简便,快速,重复性好,可用于该制剂的质量控制。
Objective: To establish a simultaneous determination method of tetrandrine, tetracycline, and berberine hydrochloride in Fengtongan capsules (Fangji, Tongcao, Papaya, Cork, etc.). Method: High performance liquid chromatography. The column was a Phenomenex Gemini C18 (4.6 mm×250 mm, 5 μm) column; mobile phase: methanol-acetonitrile-phosphate buffer (0.01 mol/L potassium dihydrogen phosphate and 0.01 mol/L sodium heptane sulfonate were mixed, Contain 0.2% triethylamine and adjust the pH to 3.0 with phosphoric acid (25:20:55); detection wavelength is 230nm. Results: There was a good linear relationship between the content of tetrandrine and the peak area in the range of 0.05152~0.8243μg, r=0.9999, the average recovery was 97.23%, and the RSD was 1.3% (n=9); There was a good linear relationship between the range of 0.03520-0.5632 μg and the peak area, r=0.9999, the average recovery was 99.56%, RSD was 1.6% (n=9), and the berberine hydrochloride injection volume was in the range of 0.03136-0.5018 μg. There was a good linear relationship with the peak area, r=0.9997, the average recovery was 98.22% and the RSD was 1.5% (n=9). Conclusion: The method is simple, rapid, and reproducible. It can be used for quality control of the preparation.