HPLC法测定依替巴肽注射液中主药及杂质相关肽的含量

Determination of Eptifibatide and Related Peptide in Eptifibatide Injection by HPLC

目的:建立以高效液相色谱法测定依替巴肽注射液中主药及杂质相关肽含量的方法。方法:色谱柱为Aichrom-Bond-AQC18,流动相为乙腈-水(含0.13%三氟乙酸),流速为1.0mL·min-1,检测波长为220nm,柱温为25℃,进样量为20μL。结果:依替巴肽检测浓度的线性范围为75.2～1203.6μg·mL-(1r=0.9999),平均回收率为99.73%～99.95%,RSD=0.26%。结论:本方法操作简便、快速,适用于该制剂中主药及杂质相关肽的含量测定。

OBJECTIVE： To establish an HPLC method for determination of major component and related peptide in eptifibatide injection. METHODS： The determination was performed on AichromBond-AQ C18 column with column temperature at 25 ℃ and flow rate of 1.0 mL.min^-1. The mobile phase consisted of acetonitrile-water （0.13% trifluoroacetic acid）. The detection wavelength was set at 220 nm and injection volume was 20 uL. RESULTS： The linear range was 75.2-1 203.6 ug.mL^-1 （r=0.999 9） with mean recovery of 99.73%-99.95% （RSD=0.26%）. CONCLUSION： The method is simple and rapid and it is applicable for determination of major component and related peptide in eptifibatide injection.