HPLC法测定氨甲环酸胶囊中氨甲环酸的含量

Determination of tranexamic acid in tranexamic acid capsules by HPLC

目的建立用于测定氨甲环酸胶囊中氨甲环酸含量的HPLC法。方法采用Karomasil-C_(18)ODS(250 mm×4.6 mm,5μm)色谱柱。流动相为磷酸盐缓冲液(pH值为2.5)-甲醇(60:30,V/V);检测波长:220 nm,流速:1.0 mL·min^(-1)。结果线性范围0.4～2.0 g·L^(-1),r=0.999 4。回收率为100.7%,RSD=0.64%(n=6)。结论本方法简便,精确,重现性好,可用于控制氨甲环酸胶囊中氨甲环酸的内在质量。

AIM To establish a method for the determination of the content of tranexamic acid in tranexamic acid capsules by HPLC. METHODS A Karomasil- C18 ODS（250 mm×4.6 mm, 5 μm） was used . The mobile phase was phosphate buffer solution（ pH = 2.5） - methanol（60：30, V/V）. The detennination wave length was 220 nm and the flowrate was 1.0 mL·min^- 1. RESULTS The method was linear within the range of 0.4 - 2.0 g·L^- 1 ; r = 0. 999 4. The average recovery rate was 100.7 % （RSD = 0.64 %, n = 6） . CONCLUSION The method is easy, rapid , accurate and reproducible. It can be a quality control standard for tranexamic acid capsules.