Simultaneous Determination of 7 Constituents in Xiaoshuan Enteric-coated Capsules by HPLC-wavelength Switching Method / 中国药房

ABSTRACT

OBJECTIVE： To establish a method for simultaneous determination of 7 active constituents in Xiaoshuan enteric-coated capsules， such as chlorogenic acid， amygdalin， paeoniflorin， ferulic acid， senkyunolide Ⅰ， calycosin glycoside and ligustilide. METHODS： HPLC method was adopted. The determination was performed on Agilent Eclipse Plus C18 column with mobile phase consisted of acetonitrile-0.1％ phosphoric acid （gradient elution）. The detection wavelengths were set at 326 nm for chlorogenic acid， 210 nm for amygdalin， 230 nm for paeoniflorin， 321 nm for ferulic acid， 334 nm for senkyunolideⅠ， 274 nm for calycosin glycoside and 260 nm for ligustilide. The flow rate was set at 1.0 mL/min， and the column temperature was 35 ℃. The sample size was 10 μL. RESULTS： The linear range was 1.16-34.81 μg/mL for chlorogenic acid， 1.85-55.48 μg/mL for amygdalin， 13.22-396.50 μg/mL for paeoniflorin， 13.50-405.09 μg/mL for ferulic acid， 1.75-52.51 μg/mL for senkyunolideⅠ， 2.74-82.18 μg/mL for calycosin glycoside， 7.67-230.07 μg/mL for ligustilide （r＝0.999 1-0.999 7）， respectively. The limit of quantity were 0.056， 0.103， 0.085， 0.013， 0.136， 0.184 and 0.276 μg. RSDs of precision， stability （24 h） and reproducibility tests were lower than 2.0％ （n＝6）. Average recoveries were 99.3％，98.6％，98.8％，99.7％，97.1％，97.6％ and 99.2％ （RSD＜2.0％， n＝6）. CONCLUSIONS： Established method is accurate and simple. It can be used for simultaneous determination of 7 constituents in Xiaoshuan enteric-coated capsules.