文章摘要
周琳.炎立消片含量测定方法的改进[J].中国药品标准,2018,19(6):477-481
炎立消片含量测定方法的改进
Improvment of Determination of Protocatechic Acid in Yanlixiao Tablets by HPLCZhou Lin<sub>(Yongzhou Institutle for Drug Control of Hunan Province , Yongzhou 425000)</sub>
投稿时间:2018-09-17  修订日期:2018-12-03
DOI:
中文关键词: 炎立消片  原儿茶酸  含量测定
英文关键词: Yanlixiao Tablets  Protocatechic Acid  assay
基金项目:湖南省食品药品监督管理局食品药品安全科技项目 项目编号:湘食药科R201724
作者单位E-mail
周琳* 湖南省永州市食品药品检验所 393789874@qq.com 
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中文摘要:
      目的:改进炎立消片中原儿茶酸的含量测定方法。方法:用依利特Hypersil ODS2(4.6mm×250mm,5µm)色谱柱;以甲醇-水-冰醋酸(5:95:1)为流动相;流量1.0mL?min-1;检测波长258nm;柱温30℃;进样量20µL。结果:原儿茶酸进样量在0.026~0.39µg范围内与峰面积呈良好的线性关系(r=0.99998),平均回收率为92.08%,其RSD为3.66%(n=6)。用本方法和现行标准方法测定3批样品,原儿茶酸含量分别为0.078mg?片-1(RSD=1.2%)、0.070mg?片-1(RSD=1.1%)、0.066mg?片-1(RSD=0.9%和0.071mg?片-1(RSD=1.9%)、0.063mg?片-1(RSD=2.3%)、0.053mg?片-1(RSD=2.1%)。结论:本方法能更准确的测定炎立消片中原儿茶酸含量、大大提高色谱柱使用寿命。
英文摘要:
      Objective:To improve the determination method of Protocatechic Acid in Yanlixiao tablets. Method:The separation was performed on a Yilite Hypersil ODS2(4.6mm×250mm,5µm) column at 30℃ with the flow phase of methanol - water - glacial acetic acid (5:95:1) and the flow rate as 1.0mL?mim-1.The detection wavelength was 258nm , and the injection volume was 20µL. Results: There was the good linearity in the rang of 0.026~0.39µg(r=0.99998) between the peak area and concentration of Protocatechic Acid . The average recovery was 92.08% with RSD as 3.66% (n=6). Three batches of samples were determined by this method and the current standard method.The content of Protocatechic Acid was 0.078mg?tablet-1(RSD=1.2%), 0.070mg?tablet-1(RSD=1.1%),0.066mg?tablet-1(RSD=0. 9%),and 0.071mg?tablet-1(RSD=1.9%),0.063mg?tablet-1(RSD=2.3%),0.053mg?tablet-1 (RSD=2.1%), respectively. Conclusion: The method is more accurate which is used for determination of Protocatechic Acid in Yanlixiao tablets . It increase service life of column greatly.
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