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-C_(18)ODS(250 mm×4.6 mm,5μm)was used.The mobile phase was phosphate buffer solution(pH=2.5)-methanol(60:30,V/V).The determination wave length was 220 nm and the flow- rate 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 av- erage recovery rate was 100.7%(RSD=0.64%,n=6).CONCLUSION The method is easy,rapid,accurate and re- producible.It can be a quality control standard for tranexamie acid capsules