HPLC法测定尿多酸肽注射液中马尿酸及苯乙酰谷氨酰胺的含量

Determination of hippuric acid and phenylacetylglutamine in uroacitides injection by HPLC

目的建立高效液相色谱(HPLC)法同时测定尿多酸肽注射液中马尿酸、苯乙酰谷氨酰胺含量的方法。方法采用LunaC18柱,流动相为甲醇-水-冰醋酸(180∶820∶4.5),流速1.0 ml.min-1,柱温40℃,检测波长225 nm。结果马尿酸、苯乙酰谷氨酰胺回收率分别为100.4%、101.1%,RSD分别为0.82%、1.69%。结论该方法简便、准确、可靠,可作为尿多酸肽注射液的质量控制方法。

Objective To establish an HPLC method for the determination of hippuric acid and phenylacetylglutamine in uroacitides injection.Methods The determination was performed on Luna C18 column,with mobile phase consisting of methanol-water-acetic acid（180∶ 820∶ 4.5）.The flow rate was 1.0 ml·min-1.Column temprature was 40℃.The detection wave length was 225 nm.Results The average recoveries of hippuric acid and phenylacetylglutamine were 100.4%,101.1% and RSD were 0.82%,1.69% respectively.Conclusion The determination method is simple,accurate,reliable,which can be used for quality control of uroacitides injection.