高效液相色谱法测定复方氨基酸(15)双肽(2)注射液中2种杂质的含量测定

HPLC determination of 2 impurities in compound amino acids(15) and dipeptides(2) injection

目的：建立同时测定复方氨基酸（15）双肽（2）注射液中焦谷氨酸和环（甘氨酰-谷氨酰胺）含量的HPLC方法。方法：使用Aglient ZORBAX SB-C18色谱柱（250 mm×4.6 mm,5μm）,流动相为0.01 mol·L^-1磷酸氢二铵溶液（用磷酸调节pH至1.6）,流速为1.0 mL·min^-1;紫外检测波长为205 nm;柱温为15℃;进样量为50μL。结果：焦谷氨酸和环（甘氨酰-谷氨酰胺）浓度分别在25.15-503.0 mgL·L^-1和40.1-802.0 mg·L^-1范围内线性关系良好,最低检测限（S/N=3）分别为75.45 ng和40.1 ng,平均回收率分别为100.9%和100.8%。结论：本方法用于复方氨基酸注射液中焦谷氨酸和环（甘氨酰-谷氨酰胺）含量的快速分析,方法简便、准确。

Objective：To establish a method for determination of oleyl pyroglutamate and cyclo（Gly-Gln） in compound amino acids（15） and dipeptides（2） injection by HPLC.Methods：Aglient ZORBAX SB-C18（250 mm×4.6 mm,5 μm） column was adopted.The mobile phase was 0.01 mol·L-1 ammonium dibasic phosphate solution（adjust pH to 1.6 with phosphoric acid） at a flow rate of 1.0 mL·min-1,and the detection wavelength was 205 nm.Results：The method had a good linearity in the range of 25.15-503.0 mg·L-1 for oleyl pyroglutamate and 40.1-802.0 mg·L-1 for cyclo（Gly-Gln）.The LODs（S/N=3） of oleyl pyroglutamate and cyclo（Gly-Gln） were 75.45 ng and 40.1 ng.The recoveries were 100.9% and 100.8%.Conclusion：The method is simple and accurate,and may be used to fast analysis of content determination.