目的: 建立测定阿维巴坦钠起始物料(2S,5R)-5-[(苄氧基)氨基]哌啶-2-羧酸乙酯含量的方法。方法: 采用Hypersil ODS2色谱柱(4.6 mm×250.0 mm,5.0 μm),流动相A为0.01 mol/L磷酸二氢铵溶液,流动相B为乙腈,流动相A到流动相B(50∶50)运行时间11 min,流速为1.0 mL/min,波长为210 nm,柱温为40 ℃,进样量为10 μL。结果: 阿维巴坦钠起始物料(2S,5R)-5-[(苄氧基)氨基]哌啶-2-羧酸乙酯都得到良好的分离。结论: 高效液相色谱法灵敏、快速、准确、可靠,可用于阿维巴坦钠起始物料(2S,5R)-5-[(苄氧基)氨基]哌啶-2-羧酸乙酯含量测定。
Objective: To establish a HPLC method to determine the content of the starting material of Avibactam sodium (2S,5R)-Ethyl 5-[(benzyloxy)amino] piperidine-2-carboxylate. Methods: Hypersil ODS2 chromatographic column(4.6mm×250mm, 5μm)was used.Mobile phase A was 0.01 mol/L ammonium dihydrogen phosphate solution, and mobile phase B was acetonitrile. The running time from mobile phase A to mobile phase B (50:50) was 11 minutes with the flow rate of 1.0 mL/min, the wavelength of 210 nm, the column temperature of 40 ℃ and the calibration amount of 10 μL. Results: Avibactam Sodium starting material (2S,5R)-Ethyl 5-[(benzyloxy)amino] piperidine-2-carboxylate was well separated. Conclusion: HPLC is sensitive, rapid, accurate and reliable to determine the content of Avibactam starting material (2S,5R)-Ethyl 5-[(benzyloxy)amino] piperidine-2-carboxylate.
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