The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the impurity analysis of tranexamic acid. The analysis was performed on a Thermo Scientific Hypersil GOLD HPLC column using the method described in the EP 8.0 monograph. Resolution between tranexamic acid and impurity C in reference solution (b) was 3.5 (exceeding EP criteria of minimum 1.5). Relative retention time of impurity C, D and B with reference to tranexamic acid was 1.15, 1.22 and 1.54 minute respectively (meeting EP criteria about 1.1, 1.3 and 1.5 min respectively for impurity C, D and B ).
In this work the separation of tranexamic acid and impurities was performed using the Thermo Scientific Hypersil GOLD HPLC column according to the method described in the BP.
