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作 者:黄丽 HUANG Li(Xiamen Institute for Food and Drug Control,Xiamen 361012,China)
机构地区:[1]厦门市食品药品质量检验研究院,福建厦门361012
出 处:《中国药品标准》2024年第4期392-397,共6页Drug Standards of China
摘 要:目的:建立同时测定紫龙金片中新绿原酸、绿原酸、咖啡酸、隐绿原酸、阿魏酸、野黄芩苷、丹酚酸B、芹菜素含量的超高效液相色谱法。方法:采用Waters Acquity UPLC HSS T3(2.1 mm×100 mm, 1.8μm)色谱柱,以乙腈-0.1%磷酸进行梯度洗脱,进样量1μL,柱温为30℃,流速为0.3 mL·min^(-1),检测波长为323 nm。结果:8种成分在各自质量浓度范围内线性关系良好(r>0.999 0),平均加样回收率94.1%~101.6%,RSD%0.70%~1.93%。测定4批样品,不同批次样品除新绿原酸、绿原酸、隐绿原酸含量略有差异,其余成分含量基本一致。结论:本法简便、高效、准确,可综合全面地评价本品的内在质量,更好地为紫龙金片的质量评价提供参考。Objective:To establish a UPLC method for the simultaneous determination of neochlorogenic acid,chlorogenic acid,caffeic acid,cryptochlorogenic acid,ferulic acid,scutellarin,salvianolic acid B,and apigenin in Zilongjin tablets.Methods:Waters Acquity UPLC HSS T3 column(2.1 mm×100 mm,1.8μm)was used.Gradient elution was performed with acetonitrile and 0.1%phosphoric acid.The injection volume was 1μL,the column temperature was set at 30℃the flow rate was 0.3 mL·min^(-1),and detection was carried out at 323 nm.Results:The linear relationship between the 8 components within their respective mass concentration ranges was good(r>0.9990),with average recovery of 94.1%to 101.6%and RSD%of 0.70%to 1.93%.Four batches of samples were tested,and the content of the other components in different batches was basically same,except slight differences in the content of neochlorogenic acid,chlorogenic acid,and cryptochlorogenic acid.Conclusion:This method is simple,efficient,and accurate,and can comprehensively evaluate the intrinsic quality of this product,which provides a better reference for the quality evaluation of Zilongjin tablets.
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