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作 者:刘志海 彭啟丽 王丹丹 金昭 LIU Zhihai;PENG Qili;WANG Dandan;JIN Zhao(Guizhou Province Qianxinan Institution for Inspection and Testing Center,Xingyi 562400,China)
机构地区:[1]贵州省黔西南州检验检测中心,贵州兴义562400
出 处:《品牌与标准化》2024年第5期4-6,10,共4页
基 金:贵州省2022年度省级药品探索性研究课题。
摘 要:目的:建立消炎止咳胶囊中槲皮素和山柰素的UPLC含量测定方法,提高该制剂质量控制标准。方法:采用UPLC含量测定方法。色谱条件:以BEH C18(2.1 mm×150 mm,1.7μm)为分离柱;以乙腈-0.4磷酸溶液(25∶75)为流动相;检测波长:370 nm;柱温:30℃;流速:0.3 m L/min,进样体积:2μL。结果:槲皮素在1.7365~17.3620μm/mL内呈良好的线性关系(R2=0.9999,n=5);加样回收率为99.5%,RSD为1.0%。山柰素在2.4516~24.5154μm/mL内呈良好的线性关系(R2=0.9999,n=5);加样回收率为98.2%,RSD为1.2%。结论:建立了消炎止咳胶囊中槲皮素和山柰素的UPLC测定方法,可有效控制该制剂的质量。Objective:To develop a UPLC method for simultaneous determination of quercetin and kaempferol in Xiaoyan Zhike Capsules and enhancing the quality control standard of the preparation.Methods:The UPLC content determination method is employed.Chromatographic conditions:BEH C18(2.1 mm×150 mm,1.7μm)column is used for separation;acetonitrile-0.4 phosphoric acid solution(25∶25)served as the mobile phase;the detection wavelength is 370 nm;the column temperature is 30℃;the flow rate is 0.3 mL/min,and the injection volume is 2μL.Results:The linear ranges of quercetin is 1.7365~17.3620μg/mL(R2=0.9999,n=5);the recoveries are 99.5%with an RSD of 1.0%.The linear ranges of kaempferol is 2.4516~24.5154μg/mL(R2=0.9999,n=5);the spiked recoveries are 98.2%and the RSD is 1.2%.Conclusion:AUPLC method for determining quercetin and kaempferol in Xiaoyan Zhike capsules is established,effectively contributing to the quality control of this preparation.
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