奥沙利铂静脉输液的有关物质检查与含量测定

目的建立测定奥沙利铂静脉输液中有关物质和奥沙利铂含量的高效液相色谱(HPLC)法。方法采用HPLC法测定奥沙利铂静脉输液的有关物质和奥沙利铂的含量,Polaris C18-A色谱柱(200 mm×4.6 mm,5μm),流动相为甲醇-水(10∶90),流速为0.8 mL/min,检测波长为249 nm,理论板数按奥沙利铂峰计不低于2 000。等渗调节剂甘露醇采用经典的氧化还原法,用硫代硫酸钠滴定液进行回滴定测定。结果奥沙利铂进样质量浓度在0.10～1.00 g/L范围与峰面积线性关系良好(r=0.999 8),最低检测限为0.06μg,平均回收率为100.17%(RSD=0.53%)。甘露醇平均回收率为100.54%(RSD=0.34%)。结论该方法专属性好,准确、灵敏、快速,结果可靠。

Determination of Content and Related Substances of Oxaliplatin Intravenous Infusion

Objective To establish a HPLC method to determine the oxaliplatin content and the related substances of oxaliplatin in-travenous infusion. Methods The HPLC method was adopted to determine the oxaliplatin content and related substances in oxali-platin intravenous infusion. The Polaris C18-A column （200mm×4.6mm,5μm） was adopted with methanol-water（10 ： 90） as the mobile phase at the flow rate of 0. 8 mL/min. The detection wavelength was set at 249 nm. The theoretical plate number was not less than 2 000 according to the peak of oxaliplatin. At the same time, the classic oxidimetry method for the determination of isotonic regulator mannite was established, which using the back titration with sodium thiosulfate titrant. Results The linear relation of oxali- platin was excellent within the concentration range of 0. 10-1.00 g/L（ r=0. 999 8）,the limit of the detection was 0.06 μg. The aver-age recovery rates of oxaliplatin and mannitol were 100. 17% （ RSD = 0.53% ） and 100. 54% （ RSD = 0.34% ）, respectively. Conclusion This method is specific, accurate, sensitive and raoid with the reliable detection Results .