顺铂冻干粉的含量测定

Determining of Content in the Freeze-drying Preparation of Cisplatin

中文关键词:  高效液相色谱法,顺铂,冻干粉

英文关键词:HPLC,cisplatin,freeze-drying preparation

中文摘要:

      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.

英文摘要:

      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).