高效液相色谱法测定氨甲环酸注射液的含量和有关物质

 目的 建立反相高效液相色谱法，测定氨甲环酸注射液的含量，并考察其有关物质。方法 以C₁₈柱为固定相；以0.23% 十二烷基硫酸钠溶液（取磷酸二氢钠18.3 g，加水800 mL溶解，加三乙胺8.3 mL混匀后，再加入2.3 g十二烷基硫酸钠，溶解混匀，用磷酸调节pH至2.5，加水至1 000 mL）-甲醇（60∶40）为流动相；检测波长为220 nm。结果 氨甲环酸在0.54～5.38 g·L-1内线性关系良好，相关系数0.999 9，最低检测限75 ng，低、中、高3种浓度的平均回收率分别为99.8%，100.4%，100.1%。结论 本方法准确、简便，专属性强，可用于氨甲环酸注射液的含量测定和有关物质的考察。

Determination of Tranexamic Acid Injection and Its Related Substances by RP-HPLC

OBJECTIVE To establish a reverse-phase high performance liquid chromatography for the determination of tranexamic acid injection and its related substances. METHODS The separation was performed on a C₁₈ column，with the mobile phase contain 0.23% of sodium laurilsulfate(dissolve 18.3 g of sodium dihydrogen phosphate in 800 mL of water, add 8.3 mL of trithylamine and 2.3 g of sodium laurilsulfate, adjust to pH 2.5 with phosphoric acid and dilute to 1 000 mL with water.) - methanol (60∶40). The detection wavelength was set at 220 nm. RESULTS A good relationship was observed in the concentration range of 0.54-5.38 g·L-1, with the coefficient of 0.999 9. The limit of detection (LOD) was 75 ng. The average recovery of three concentrations were 99.8％，100.4% and 100.1％, respectively. All the related substances were separated from the target peak. CONCLUSION The method was proved to be accurate, sensitive and showed highly specific. It can be applied for the assay, as well as the related substances of tranexamic acid injection.