HPLC法同时测定乙肝扶正胶囊中6种化学成分的含量

目的:建立同时测定乙肝扶正胶囊中多种指标成分含量的方法。方法:采用高效液相色谱法。色谱柱为DiamonsilTMC18(250mm×4.6mm,5μm),流动相为乙腈-甲醇-0.1%醋酸水溶液(梯度洗脱),柱温为30℃,没食子酸、虎杖苷、白藜芦醇与二苯乙烯苷的检测波长均为320nm,肉桂醛和丹参酮ⅡA的检测波长均为254nm。结果:没食子酸、虎杖苷、二苯乙烯苷、白藜芦醇、肉桂醛、丹参酮ⅡA的质量浓度分别在0.12200～0.85400、0.00588～0.04116、0.01360～0.09520、0.00208～0.01456、0.04352～0.30460、0.00640～0.04480mg·mL-1范围内与各自峰面积积分值呈良好的线性关系(r>0.9990);平均加样回收率分别为99.9%、99.8%、102.3%、100.5%、101.2%、100.1%,RSD分别为2.5%、1.6%、1.5%、2.1%、1.9%、1.4%(n均为6)。结论:本方法专属性强、灵敏、快速,结果准确、可靠,可用于乙肝扶正胶囊的质量控制。

Simultaneous Determination of 6 Chemical Constituents in Yigan Fuzheng Capsules by HPLC

OBJECTIVE： To establish the method for simultaneous determination of many constituents in Yigan fuzheng cap- sule. METHODS： HPLC method was used. The determination was performed on DiamonsilTM C18（250mm×4.6mm,5μm）column with mobile phase consisted of acetonitrile-methanol-0.1% acetic acid solution （gradient elution）. The detection wavelength was set at 320 nm for gallic acid, polygonin, resveratrol and stilbene glycoside, that of cinnamaldehyde and tanshinone Ⅱ A was set at 254 nm. The column temperature was 30℃. RESULTS： The linear ranges were 0.122 00-0.854 00 mg·mL^-1 for gallic acid, 0.005 88- 0.041 16 mg·mL^-1for polygonin, 0.013 60-0.095 20 mg.mL 1 for stilbene glycoside, 0.002 08-0.014 56 mg·mL^-1 for resvera- trol, 0.043 52-0.304 60 mg·mL^-1 for cinnamaldehyde and 0.006 40-0.044 80 mg.mL-1 for tanshinone ⅡA （r〉0.999 0）. Average recoveries were 99.9%, 99.8%, 102.3%, 100.5%, 101.2%, 100.1%, and RSDs were 2.5%, 1.6%, 1.5%, 2.1%, 1.9%, 1.4% （n=6）. CONCLUSION： The method is specific, sensitive, rapid, accurate and reliable, and it can be used for the quality control of Yi-an fuzhene capsules.