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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,5μm),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。
Objective To establish a HPLC method for the determination of ertapenem for injection and its related substances. Methods Inertsil ODS C18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase A with 0.01 mol·L -1 ammonium acetate solution. Acetonitrile was used as mobile phase B and gradient elution was performed at a flow rate of 1.0 mL · min -1. The column temperature was 25 ℃, the detection wavelength is 230 nm. Results Ertapenem had a good linear relationship in the range of 0.17-0.87 mg · mL -1, r = 0.999 7 with the lowest detection concentration of 17 ng · mL 1, oxazinone, pro-maba, ring-opening degradation products and dimers Related substances in the chromatographic conditions were well separated. Conclusion This method has good reproducibility and specificity. It can be used to determine the content of ertapenem for injection and related substances.