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作 者:车爽 周军 曲佳 Che Shuang;Zhou Jun;Qu Jia(Tianjin Institute for Drug Control,Tianjin 300000)
出 处:《天津药学》2021年第3期16-18,共3页Tianjin Pharmacy
摘 要:目的:建立HPLC法测定妇康宝口服液中阿魏酸含量的方法。方法:色谱柱为phenomenex Luna C18(2)100■(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-0.1%磷酸水溶液体系梯度洗脱,流速为1.0 ml/min,检测波长为321 nm,柱温为35℃。结果:阿魏酸在1.5890~10.5930μg/ml浓度范围内呈现良好线性(r=1.0000),精密度(RSD为1.7%)和重复性(RSD为1.1%)良好,在24 h内稳定性良好(RSD为1.8%),加样回收率平均值为97.13%(RSD为2.0%)。结论:建立的HPLC测定阿魏酸含量的方法,方法简便、快捷、准确,可作为有效评价该制剂质量的方法。Objective:To establish an HPLC method for the determination of ferulic acid in Fukangbao oral liquid.Methods:The method was performed on the reversed-phase column of phenomenex Luna C18(2)100■(250 mm×4.6 mm,5μm).The mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution,and the flow rate was 1.0 ml/min.The detective wavelength was set at 321 nm,and the column temperature was 35℃.Results:The calibration curve of ferulic acid had good linearity in the concentration range of 1.5890~10.5930μg/ml(r=1.0000).The RSD of precision(RSD was 1.7%)and repeatability(RSD was 1.1%)were good,and the stability was also good within 24 h(RSD was 1.8%).The average recovery was 97.13%(RSD was 2.0%).Conclusion:A rapid,simple,and accurate HPLC method was established for the determination of ferulic acid,and it could be used for the quality control of Fukangbao oral liquid.
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