Simultaneous determination of 15 bioactive compounds in Fufang Zhenzhu Tiaozhi capsules by HPLC-DAD-ELSD

HPLC-DAD-ELSD法同时测定复方贞术调脂胶囊15个活性成分(英文)

Fufang Zhenzhu Tiaozhi capsules （FTZc）, which is consisted of eight traditional Chinese herbal medicines and contains multiple bioactive ingredients, is a patented and clinically approved herbal formulation for the treatment of dyslipidemia. A feasible HPLC-DAD-ELSD method was developed to simultaneously determine 15 bioactive compounds （salidroside, specneuzhenide, magnoflorine, rosmarinic acid, salvianolic acid B, columbamine, jatrorrhizine, epiberberine, coptisine, palmatine, berberine, 5,7-dimethoxycoumarin, ginsenoside Rgl, ginsenoside Rbl and oleanic acid ） in FTZc for its quality control. The multiple wavelength detection mode of DAD was used. The chromatographic separation was performed on an Ultimate XB Cls column with gradient elution. The mobile phase A （acetonitrile） and B （0.25% glacial acetic acid and 0.13% triethylamine in water, v/v） were run at a flow rate of 0.8 mL/min. The developed method showed good precision and accuracy with overall intra- and inter-day variations of 0.7%-1.9% and 0.6%-3.0%, respectively. The recoveries measured at three concentration levels, varied from 95.5% to 103.8%. The validated method was successfully applied for the simultaneous determination of 15 bioactive compounds in three batches of FTZc. The results suggested that the developed method was convenient and reliable, particularly suitable for the routine quality control of FTZc.

复方贞术调脂胶囊(FTZc)是一种用于治疗高脂血症的专利药物,由八味中药组成,含有多活性成分的复方制剂。本文建立了可行的HPLC-DAD-ELSD方法用于FTZc的质量控制,同时测定15个活性成分(红景天苷、特女贞苷、木兰碱、迷迭香酸、丹酚酸B、非洲防己碱、表小檗碱、药根碱、黄连碱、巴马汀、小檗碱、5,7-二甲氧基香豆素、人参皂苷Rg1、人参皂苷Rb1和齐墩果酸)。色谱柱采用Ultimate XB C18,流动相为乙腈–水(0.25%乙酸,0.13%三乙胺)(梯度洗脱),流速为0.8mL/min,检测方法采用光电二极管阵列检测器的多波长检测模式和蒸发光散射检测器联合应用。方法学验证表明该方法精密度、准确度良好,成功用于不同批次FTZc的测定。结果表明,本文建立的测定多种生物活性成分HPLC-DAD-ELSD方法切实可行、方法可靠,特别适用于复方贞术调脂胶囊的质量评价。