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目的:建立反相高效液相色谱法同时测定医院制剂加味白头翁汤凝胶灌肠剂中秦皮甲素和盐酸小檗碱的含量。方法:色谱柱为DiamonsilC18(250mm×4.6mm,5μm);采用梯度洗脱的方法,流动相:溶液A为乙腈,溶液B为含5%三乙胺的0.33mol·L-1磷酸二氢钾缓冲液(pH=3.0)。0～9min,溶液A:溶液B为12∶88;9～10min,A∶B为30∶70;10～22min,A∶B为30∶70。流速:1.0mL·min-1;秦皮甲素和盐酸小檗碱的检测波长分别为334nm和349nm。结果:秦皮甲素和盐酸小檗碱分别在4～200μg·mL-1和1～50μg·mL-1范围内线性良好;平均加样回收率分别为96.63%(RSD=2.52%)和97.37%(RSD=1.84%)。结论:本方法准确、重现性好,可用于加味白头翁汤凝胶灌肠剂的质量控制。
Objective: To establish an RP-HPLC method for the simultaneous determination of aescinate and berberine hydrochloride in the medicinal Pulsatilla Tang’s gel enema. Methods: The column was Diamonsil C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile as mobile phase A and 0.33 mol·L-1 potassium dihydrogen phosphate with 5% triethylamine Buffer (pH = 3.0). 0 ~ 9min, solution A: solution B is 12:88; 9 ~ 10min, A:B is 30:70; 10 ~ 22min, A:B is 30:70. The flow rate was 1.0 mL · min-1. The detection wavelength of aescinate and berberine hydrochloride were 334 nm and 349 nm, respectively. Results: Aesculin and berberine were linear in the range of 4 ~ 200μg · mL-1 and 1 ~ 50μg · mL-1 respectively. The average recoveries were 96.63% (RSD = 2.52%) and 97.37% (RSD = 1.84%). Conclusion: The method is accurate and reproducible, and can be used for quality control of flavored Pulsatilla root gel enema.