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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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HPLC-DAD法同时测定凝胶膜剂中氨甲环酸和维生素C乙基醚的含量

Simultaneous determination of tranexamic acid and 3-O-ethyl ascorbyl ether in compound gel by HPLC-DAD

分类号:R917
出版年·卷·期(页码):2020,40 (5):809-813
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立HPLC-DAD法用于同时测定凝胶膜剂中氨甲环酸和维生素C乙基醚的含量。方法:采用Ultimate XB C18 (250 mm×4.6 mm,5 μm)色谱柱,以pH 2.5磷酸盐缓冲液-甲醇(60:40)为流动相;流速为0.9 mL·min-1;氨甲环酸检测波长为220 nm,维生素C乙基醚检测波长为245 nm;进样量20 μL;柱温30℃。结果:凝胶膜剂中氨甲环酸和维生素C乙基醚质量浓度分别在0.020 1~4.016 8 mg·mL-1和0.005 0~0.353 4 mg·mL-1线性范围内与峰面积线性关系良好,平均回收率(n=3)分别为100.8%和95.5%,RSD分别为2.2%和1.4%;两者的日内和日间精密度均值均小于2%;含量测定结果均在95.0%~105.0%。结论:该方法准确、简便,专属性强,重现性好,可作为该制剂的质量控制方法。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To develop an HPLC coupled with diode array detection (DAD) method for the simultaneous determination of tranexamic acid and 3-O-ethyl ascorbyl ether in compound gel. Methods: The Ultimate XB C18 (250 mm×4.6 mm,5 μm)column was used at 30℃,the mobile phase was consisted of phosphate buffer (pH 2.5)-methanol (60:40) at 0.9 mL·min-1,the injection volume was 10 μL. The detection wavelengts of tranexamic acid and 3-O-ethyl ascorbyl ether were 220 nm for tranexamic acid and 245 nm for 3-O-ethyl ascorbyl ether,respectively. Results: Above-mentioned 2 compounds were separated well and showed an excellent linear relationship in 0.020 1-4.016 8 mg·mL-1 and 0.005 0-0.353 4 mg·mL-1,respectively. The average recovery rates(n=3)of tranexamic acid and 3-O-ethyl ascorbyl ether were 100.8% (RSD=2.2%) and 95.5% (RSD=1.4%),respectively. The RSDs of intra -day and inter-day were less than 2%. The determination results of both were between 95.0%-105.0%. Conclusion: The method is accurate,simple,highly specific and reproducible,which is applicable for the quality control of compound tranexamic acid gel.

-----参考文献:---------------------------------------------------------------------------------------
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