顺铂冻干粉的含量测定

Determining of Content in the Freeze-drying Preparation of Cisplatin

  • 摘要: 建立了顺铂冻干粉注射液含量测定方法的正相高效液相色谱法,色谱条件为:氨基键合硅胶柱,二甲基甲酰胺为样品溶剂,流动相为乙酸乙酯∶甲醇∶二甲基甲酰胺∶水(25∶16∶5∶5,V/V/V/V), 在310 nm检测, 流速1.5 mL/min,进样量20 μL.该法线性相关,相关系数r为0.999 6,回收率为99.6%~100.3%,精确度为0.21%(n=6),最小检出限为59.2 μg/L,符合含量测定要求.

     

    Abstract: A method to detect the content in the freeze-drying preparation of cisplatin was established. The method uses normal-phase high performance liquid chromatography and N,N-dimethylformamide as solvent, the mobile phase include ethyl acetate, methanol, N,N-dimethylformamide and water (the proportion of mixture is 25∶16∶5∶5,V/V/V/V).The flow rate is 1.5 mL/min, injection 20 μL and UV-310 nm as detector. This method has a good linear correlation .The recovery rate is 99.6%~100.3% and detection limit is 59.2 mg/L, the degree of accuracy is 0.21%(n=6).

     

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