摘要
目的建立HPL C法测定氨甲环酸乳膏中氨甲环酸的含量。方法供试品溶液制备条件采用正交试验优化。含量测定色谱条件采用Diamonsil C18色谱柱（250 mm×4.6 mm,5μm）;流动相0.23%十二烷基硫酸钠溶液-甲醇（60∶40,v/v）;检测波长220 nm;流速0.8 mL·min-1;柱温30℃;进样量20μL。结果提取溶剂为水-甲醇溶液（5∶5,v/v）,80℃水浴搅拌加热4 min,冷却后定容,冰浴1.5 h,0.22μm微孔滤膜滤过。乳膏基质不影响氨甲环酸乳膏的含量测定。氨甲环酸在0.500 5~4.040 mg·mL-1峰面积与浓度呈良好线性关系,r=0.999 0;最低检测限为0.49μg;最低定量限为1.64μg;平均回收率均〉99%,RSD均〈1.5%（n=3）。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。
Objective To determine the content of tranexamic acid in tranexamic acid cream by HPLC. Methods The preparation condition of test solution were optimized by orthogonal test. The separation was performed on a Diamonsil C18 column（250 mm×4.6 mm, 5 μm）, with the mobile phase containing 0.23% of sodium laurilsulfatemethanol（60∶40, v/v）. The detection wavelength was 220 nm, the column temperature was 30 ℃, the fl ow rate was 0.8 mL·min-1 and the injection volume was 20 μL. Results The optimal solvent for extraction was water-methanol（5∶5, v/v）. The sample solution was heated in a water bath at 80 ℃ for 4 min with stirring. Then it was cooled and adjusted into constant volume. Time in ice bath was 1.5 h. The sample solution was fi ltered by a 0.22 μm microporous membrane. The excipient had no effect on the content determination of tranexamic acid cream. A good relationship was observed at 0.500 5- 4.040 mg·mL-1, with the coeffi cient of 0.999 0. The limit of detection（LOD） was 0.49 μg. The limit of quantitation（LOQ） was 1.64 μg. The average recoveries were more than 99%（RSDs〈1.5%, n=3）. Conclusion The method is easy, rapid, accurate, reproducible and highly specifi c. It can be used to control the quality of tranexamic acid cream.
出处
《中南药学》
CAS
2014年第8期802-805,共4页
Central South Pharmacy
