Determination of Ertapenem for Injection and its Related Substances by HPLC

OBJECTIVE To develop an HPLC method for determintation of ertapenem for injection and its related substances. METHODS The column was Inertsil ODS C₁₈ (250 mm×4.6 mm, 5 μm). Mobile phase A: 0.01 mol·L^-1 ammonium acetate solution; mobile phase B: acetonitrile. The gradient elution was used with a flow rate of 1.0 mL·min^-1. The column temperature was 25 ℃. The detection wavelength was 230 nm. RESULTS The calibration curve was linear in the range of 0.17-0.87 mg·mL^-1(r=0.999 7). The limit of detection of ertapenem was 17 ng·mL^-1. The related subatances in ertapenem sodium such as oxazinone, Pro-maba, ring-opend hydrolysis product and dimers were separated successfully. CONCLUSION This method with good reproducibility and specificity, is suitable for the determination of ertapenem for injection and its related substances.