HPLC测定注射用厄他培南的含量及有关物质

Determination of Ertapenem for Injection and its Related Substances by HPLC

摘要: 目的建立高效液相色谱法测定注射用厄他培南含量及有关物质。方法采用Inertsil ODS C₁₈柱(250 mm×4.6 mm，5 μm)，0.01 mol·L^-1乙酸铵溶液为流动相A，乙腈为流动相B，梯度洗脱，流速为1.0 mL·min^-1，柱温25 ℃，检测波长为230 nm。结果厄他培南在0.17~0.87 mg·mL^-1内线性关系良好，r=0.999 7，最低检测浓度为17 ng·mL^-1，噁嗪酮、Pro-maba、开环降解物和二聚物等有关物质在该色谱条件下均分离良好。结论本法重现性好，专属性强，可用于测定注射用厄他培南的含量和有关物质。

Abstract: 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.