目的 采用HPLC-UV-ELSD同时测定复方红景天胶囊中大花红天素、没食子酸、红景天苷、酪醇、哈巴苷、哈巴俄苷、安格洛苷C、肉桂酸8种成分。方法 应用KromasiL色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.3%冰醋酸水溶液,梯度洗脱,体积流量1.0 mL/min,紫外检测波长275 nm,柱温30℃,蒸发光散射检测器漂移管温度40℃,载气N₂,压力150 kPa。结果 大花红天素、没食子酸、红景天苷、酪醇、哈巴苷、哈巴俄苷、安格洛苷C、肉桂酸8种成分能够达到很好分离;其线性范围分别为67.084~670.84(R²=0.9992)、11.410~114.100(R²=0.9994)、78.995~789.95(R²=0.9996)、19.625~196.25(R²=0.9997)、59.368~593.68(R²=0.9998)、62.585~625.85(R²=0.9995)、55.045~550.45(R²=0.9996)、6.895~68.95μg/mL(R²=0.9998);平均回收率分别为100.8%、98.9%、100.1%、100.8%、98.9%、99.6%、100.7%、99.2%,RSD分别为0.64%、0.56%、0.35%、0.65%、0.26%、0.58%、1.00%、0.64%(n=6)。结论 该方法分析简便、准确,可作为该制剂的定量分析方法。

Objective To develop an HPLC-UV-ELSD method for the simultaneous determination of crenelatin, gallic acid, salidroside, tyrosol, harpagide, harpagoside, angoroside C, and cinnamic acid in Compound Rhodiola Capsule.Methods Kromasil C₁₈ column(250 mm×4.6 mm, 5μm) was adopted.The mobile phase was composed of acetonitrile(A) and 0.3% HAC(B) with gradient elution.The flow rate was 1.0 mL/min and the detection wavelength was 275 nm.the column temperature was 30℃, and the evaporative light-scattering detector(ELSD) drift tube temperature was 40℃, and gas pressure of 1.5 bar(150 kPa).Results Crenelatin, gallic acid, salidroside, tyrosol, harpagide, harpagoside, angoroside C, and cinnamic acid were separated well.The linear calibration curves were obtained in 67.084-670.84μg/mL for crenelatin, R²=0.9992;11.410-114.100μg/mL for gallic acid, R²=0.9994;78.995-789.95μg/mL for salidroside, R²=0.9996;19.625-196.25μg/mL for tyrosol, R²=0.9997;59.368-593.68μg/mL for harpagide, R²=0.9998;62.585-625.85μg/mL for harpagoside, R²=0.9995;55.045-550.45μg/mL for angoroside C, R²=0.9996;and 6.895-68.95μg/mL for cinnamic acid, R²=0.9998.The average recoveries of the eight constituents were 100.8%, 98.9%, 100.1%, 100.8%, 98.9%, 99.6%, 100.7%, and 99.2% with RSD of 0.64%, 0.56%, 0.35%, 0.65%, 0.26%, 0.58%, 1.00%, and 0.64%.Conclusion The method is convenient, accurate, and can be used for the simultaneous determination of the preparation.

科技部重大新药创制:现代中药创新集群与数字制药技术平台(2013ZX09402203),负责人:王振中