HPLC法测定复方二氯醋酸二异丙胺氯化钠注射液中二氯醋酸二异丙胺的含量

Determination of Diisopropylamine Dichloroacetate in Compound Diisopropylamine Dichloroacetate and Sodium Chloride Injection by HPLC

目的:建立高效液相色谱法测定测定复方二氯醋酸二异丙胺氯化钠注射液中二氯醋酸二异丙胺含量的方法。方法:十八烷基硅烷键合硅胶为填充剂;以0.9%氯化钠溶液(用磷酸调节pH值至2.5)为流动相;检测波长为210nm,柱温:室温;流速:1.0mL/min;进样量:20μL。结果:该方法线性范围0.02mg/mL～0.18mg/mL,r=0.999,平均回收率99.68%,RSD为0.66%。结论:该法简单、准确、灵敏度高,重现性好,可用于本制剂中该成分的含量测定。

Objective： To establish a HPLC method for the determination of diisopropylamine dichloroacetate in Compound Diisopropylamine Dichloroacetate and Sodium Chloride Injection.Methods： A C18 column（4.6×150mm 5μm） was used;the mobile phase was 0.9% NaCl（pH2.5）;the detec ion wavelength was 210nm;the column temperature w as 25℃;the flow rate was 1.0ml/min and the injection volume was 20μL.Results： The calibration curve was linear in the range of0.02mg/mL～0.18mg/mL,r=0.999.The average recovery was 99.68% with RSD of 0.66%. Conclusions： The method is simple,accurate,sensitive and reproducible for determination of diisopropylamine dichloroacetate.