离子排斥色谱法测定复方氨基酸（15）双肽（2）注射液中醋酸含量

目的：建立复方氨基酸（15）双肽（2）注射液中醋酸含量的离子排斥色谱法。方法：采用HyperREZ XP carbohydrate H+色谱柱，以0.002 5 mol&#183;L^-1硫酸溶液为流动相，流速为0.5 mL&#183;min^-1，柱温45℃，检测波长210 nm，进样量10 μL。结果：醋酸峰与相邻色谱峰分离度良好，醋酸的线性范围为0.184 8~7.391 mg&#183;mL^-1（r=1.000，n=5）；精密度、稳定性、重复性试验的RSD<2%；加样回收率为101.5%，rsd为1.3%（n=9）。结论：建立的离子排斥色谱法可用于复方氨基酸（15）双肽（2）注射液中醋酸的含量测定。

Objective:To establish a ion exclusion chromatography(IEC)method for the determination of acetic acid in compound amino acid(15)peptide(2)injection. Methods:The column was HyperREZ XP carbohydrate H + with the mobile phase of 0.002 5 mol&#183;L^-1 sulfuric acid solution. The flow rate was 0.5 mL&#183;min^-1,the column temperature was 45℃,the detection wavelength was 210 nm,and the injection volume was 10 μL. Results:The linear range of acetic acid was 0.184 8-7.391 mg&#183;mL^-1(r=1.000,n=5).RSDs of precision,stability and repeatability tests were all lower than 2%. The recovery was 101.5%(RSD=1.3%,n=9).Conclusion:The established IEC method can be used for the determination of acetic acid in compound amino acid (15) peptide (2) injection.

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