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

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.

Simultaneous Determination of Seven Alkaloids in Fufang Zhenzhu Tiaozhi Capsule by HPLC Coupled with DAD

Objective To establish a reverse-phase liquid chromatography method for the determination of seven alkaloids(magnoflorine,columbamine,jatrorrhizine,epiberberine,coptisine,palmatine,and berberine)in Fufang Zhenzhu Tiaozhi Capsule.Methods Chromatography was performed on a Dionex Acclaim C_(18)column(250 mm×4.6 mm,5.0μm)at 30℃.The mobile phase was composed of acetonitrile-potassium dihydrogen phosphate solution(0.015 mol/L,40:60,including 1.7 g/L sodium dodecyl sulfate and phosphoric acid used to regulate pH value to 3.0),with a flow rate of 1.0 mL/min.The detection wavelength was 270 nm.Results The calibration curves of magnoflorine,columbamine,jatrorrhizine,epiberberine,coptisine,palmatine,and berberine were linear in the range of 1.07-10.65,0.78-7.55,0.75-7.50,1.60-15.95,2.69-26.85,2.31-23.10,and 6.04-60.40 mg/mL.The average recoveries of magnoflorine,columbamine,jatrorrhizine,epiberberine,coptisine,palmatine,and berberine were 101.0%,101.2%,100.1%,100.0%,100.1%,101.1%,and 99.7%,respectively.Conclusion The method could be used for the quantitative determination of the preparation.