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作 者:高忠坂 GAO Zhong-ban(Sanming Inspection and Testing Center,Sanming 365000,China)
出 处:《海峡药学》2021年第3期72-74,共3页Strait Pharmaceutical Journal
摘 要:目的建立心舒宝片中没食子酸、芍药苷、丹酚酸B 3种成分的HPLC含量测定方法,为心舒宝片的质量控制提供参考。方法采用HPLC-DAD法,岛津ODS C 18色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.15%磷酸水溶液梯度洗脱,检测波长230 nm(芍药苷)和286 nm(没食子酸、丹酚酸B),柱温30℃,流速1.0 mL·min^(-1)。结果没食子酸、芍药苷和丹酚酸B分别在127.16~1271.6 ng(r=1),292.62~2926.2 ng(r=0.9995)和39.70~397.0 ng(r=0.9995)内线性关系良好;平均加样回收率分别为102.56%,102.19%和98.34%,RSD分别为2.0%,1.8%和1.4%。结论本方法准确、可靠,可用于心舒宝片的质量控制。OBJECTIVE To stablish an HPLC method for simultaneous determination of gallic acid,paeoniflorin and salvianolic acid B in XinShuBao Tablets,and to provide the evidence for its quality control.METHODS The HPLC-DAD analysis was carried out by Shimadzu ODS C 18 column(4.6 mm×250 mm,5μm)with acetonitrile-0.15%H 3PO 4 solution as the mobile phase for gradient elution.The detection wavelength was 230 nm for paeoniflorin,280 nm for gallic acid and salvianolic acid B,respectively.In addition,the column temperature was 30℃,and the flow rate was 1.0 mL·min^(-1).RESULTS The linear range was 127.16-1271.6 ng for gallic acid(r=1),292.62-2926.2 ng for paeoniflorin(r=0.9995)and 127.16-1271.6 ng for salvianolic acid B(r=0.9995);the average recoveries were 102.56%,102.19%and 98.34%,and RSD were 2.0%,1.8%,1.4%,respectively.CONCLUSION This method is accurate and reliable,and it is suitable for the quality control of XinShuBao Tablets.
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