Simultaneous Determination of 7 Kinds of Components in Qing'e Pills by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To develop a method for simultaneous determination of psoralen,isopsoralen,bergapten,imperato-rin,trimethylpsorale,neobavaisoflavone and bavachin in Qing'e pills. METHODS:HPLC method was adopted. The separation was performed on Kinetex-C18 column with mobile phase consisted of methanol-0.1% glacial acetic (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelength was set at 248 nm. The column temperature was 30 ℃. The sample size was 20 μL. RESULTS:The linear ranges were 1.012-101.2 μg/mL for psoralen(r=0.9999),1.007-100.7 μg/mL for isopsoralen(r=0.9997), 1.010-101.0μg/mL for bergapten(r=0.9999),1.021-102.1μg/mL for imperatorin(r=0.9999),1.002-100.2μg/mL for trimethyl-psorale(r=0.9996),1.008-100.8 μg/mL for neobavaisoflavone(r=0.9999),1.025-102.5 μg/mL for bavachin(r=0.9998),re-spectively. The limits of quantitation were 0.15,0.15,0.30,0.30,0.15,0.30,0.30 μg/mL,and the limits of detection were 0.05, 0.05,0.10,0.10,0.05,0.10,0.10 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 2.0%. The recoveries were 95.3%-99.6%(RSD=1.9%,n=6),96.1%-99.3%(RSD=1.2%,n=6),95.2%-98.4%(RSD=1.4%,n=6),95.4%-99.2%(RSD=1.5%,n=6),96.1%-99.3%(RSD=1.5%,n=6),95.6%-98.9%(RSD=1.4%,n=6), 95.2%-99.6%(RSD=1.6%,n=6),respectively. CONCLUSIONS:The method is simple and accurate,can be used for simultane-ous determination of 7 kinds of components in Qing'e pills.