今日药学

2018, v.28(09) 595-598

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HPLC法同时测定心宁片中没食子酸、丹参素、原儿茶醛及芍药苷的含量
HPLC Simultaneous Determination of Gallic Acid,Tanshinol,Protocatechuic aldehyde and Paeoniflorin in Xinning Tablets

吴晓冬;苏畅;关潇滢;江玲玲;王淑红;王铁杰;
WU Xiaodong;SU Chang;GUAN Xiaoying;JIANG Lingling;WANG Shuhong;WANG Tiejie;Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research;

摘要(Abstract):

目的建立同时测定心宁片中没食子酸、丹参素、原儿茶醛及芍药苷含量的高效液相色谱(HPLC)法。方法采用Altima C18(250 mm×4.6 mm,5μm)色谱柱,流动相为甲醇-0.15%磷酸溶液,流速1.0 m L·min-1,柱温35℃,检测波长分别为273 nm、283 nm、280 nm及230 nm。结果没食子酸浓度在0.011 2~0.180 2 mg·mL~(-1)范围内(r=1.000 0),丹参素浓度在0.012 5~0.201 3 mg·mL~(-1)范围内(r=1.000 0),原儿茶醛浓度在0.001 2~0.0201 mg·mL~(-1)范围内(r=1.000 0),芍药苷浓度在0.0124~0.199 1mg·mL~(-1)范围内(r=1.000 0),与峰面积均呈良好的线性关系;平均回收率(n=6)分别为100.7%、96.7%、99.4%及102.4%,RSD均小于3.0%。结论建立的HPLC法可同时测定没食子酸、丹参素、原儿茶醛及芍药苷4种成分,方法快速、简便、结果准确,可为心宁片提供更全面、可靠的质量控制方法。
OBJECTIVE To establish a HPLC method for simultaneous determination of gallic acid,tanshinol,protocatechuic aldehyde and paeoniflorin in Xinning tablets. METHODS The samples were separated on a Altima C18( 250 mm× 4.6 mm,5 μm)column,using methanol and 0.15% phosphoric acid( B) as mobile phase at a flow rate of 1.0 m L·min-1. The column temperature was set at 35 ℃. The wavelength was set on 273 nm,283 nm,280 nm and 230 nm. RESULTS The linear ranges of gallic acid was 0.011 2-0.180 2 μg·mL~(-1)( r=1.000 0),tanshinol was 0. 012 5-0. 201 3 μg·mL~(-1)( r=1. 000 0),protocatechuic aldehyde was 0. 001 2-0.020 1 μg·mL~(-1)( r= 1.000 0),paeoniflorin was 0.012 4-0.199 1 μg·mL~(-1)( r=1.000 0),the average recoveries( n=6) were100.7%,96.7%,99.4% and 102.4% respectively,and RSD were less than 3.0%. CONCLUSION A rapid,simple,accurate HPLC method is successfully established for simultaneous determine 4 effective components in Xinning tablets. The method here in described is helpful for the quality control of Xinning tablets.

关键词(KeyWords): 心宁片;没食子酸;丹参素;原儿茶醛;芍药苷;质量控制;高效液相色谱法
Xinning tablets;gallic acid;tanshinol;protocatechuic aldehyde;paeoniflorin;quality control;HPLC

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作者(Author): 吴晓冬;苏畅;关潇滢;江玲玲;王淑红;王铁杰;
WU Xiaodong;SU Chang;GUAN Xiaoying;JIANG Lingling;WANG Shuhong;WANG Tiejie;Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research;

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