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建立HPLC梯度洗脱法测定西维来司他钠的含量及有关物质。方法:采用Shim-pack Vp-ODS C18柱,以乙腈-0.02mol.L-1磷酸二氢钾溶液(pH3.5)为流动相线性梯度洗脱,30分钟内乙腈比例由38%至80%,平衡5 min;流速:1ml/分钟;紫外检测波长为235nm。外标法定量。结果:西维来司他钠与其相邻杂质峰能完全分离,西维来司他钠在30～70μg.ml-1的浓度范围内线性关系良好(r=0.9999)。结论:该法简单,准确,专属性好,可以用于西维来司他钠的含量测定及有关物质检查。
To establish a HPLC gradient elution method for the determination of the content of sivelestat sodium and related substances. Methods: A linear gradient elution was performed on a Shim-pack Vp-ODS C18 column with acetonitrile-0.02mol.L-1 potassium dihydrogen phosphate solution (pH3.5) as the mobile phase. The ratio of acetonitrile was increased from 38% to 80% , The balance of 5 min; flow rate: 1ml / min; UV detection wavelength of 235nm. External standard method. Results: There was a complete separation of cetylisasteride from its adjacent impurity peaks. The linear relationship between cetylinitratoride sodium and 30-70 μg.ml-1 was good (r = 0.9999). Conclusion: The method is simple, accurate and specific, and can be used for the determination of the content of sivelestat sodium and related substances.