Simultaneous Content Determination of 8 Components in Xuezhikang Capsules by HPLC-DAD / 中国药房

ABSTRACT

OBJECTIVE： To establish the method for simultaneous determination of 5 isoflavones （daidzin， genistin， daidzein， glycitein and genistein） and 3 statins （lovastatin hydroxy acid， mevastatin and lovastatin） in Xuezhikang capsules. METHODS： HPLC-DAD method was adopted. The determination was performed on Shimadzu Hypersil Gold C18 column with mobile phase consisted of 0.1％ formic acid water-acetonitrile using gradient elution. The flow rate was 1.0 mL/min， and the detection wavelengths were set at 256 nm （daidzin， genistin， daidzein， glycitein and genistein） and 237 nm （lovastatin hydroxy acid， mevastatin and lovastatin）. The column temperature was maintained at 30 ℃， and sample size was 10 μL. RESULTS： The linear range of daidzin， genistin， daidzein， glycitein， genistein， lovastatin hydroxy acid， mevastatin and lovastatin were 5.01-250.20， 3.02-150.91， 2.27-113.33， 3.01-150.58， 3.61-180.43， 4.03-201.19， 3.32-166.32， 5.02-250.82 μg/mL （r＝0.999 3-0.999 9）， respectively. The detection limits were 0.25， 0.13， 0.45， 0.12， 0.21， 0.24， 0.12 and 0.15 μg/mL； the quantitation limits were 0.84， 0.36， 1.29， 0.41， 0.65， 0.78， 0.33 and 0.50 μg/mL， respectively. RSDs of precision， stability （48 h） and reproducibility tests were all no more than 3.0％ （n＝6）. Average recoveries were 97.04％， 98.49％， 99.60％， 96.14％， 101.88％， 96.20％， 101.19％， 98.46％， and RSDs were 1.76-4.79％ （n＝6）. CONCLUSIONS： The established methods is simple， sensitive， accurate， and can be applied for simultaneous content determination of daidzin， genistin， daidzein， glycitein， genistein， lovastatin hydroxy acid， mevastatin and lovastatin in Xuezhikang capsules.