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

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,5 μm),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50 μL。 结果: 焦谷氨酸和环(甘氨酰-谷氨酰胺)浓度分别在25.15~503.0 mg·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.