HPLC-外标法测定奥沙利铂甘露醇注射液中奥沙利铂含量的不确定度分析

Uncertainty analysis of the determination of oxaliplatin in Oxaliplatin and Mannitol Injection by HPLC-external standard method

目的评定以高效液相色谱-外标法测定奥沙利铂甘露醇注射液中奥沙利铂含量的不确定度。方法根据《测量不确定度评定与表示》(JJFI059-1999)中有关规定,对奥沙利铂甘露醇注射液中奥沙利铂的含量测定进行不确定度评定。结果扩展不确定度为1.14%,含量测定结果可表示为(95.9±1.2)%。不确定度主要来源为天平的称量和溶液的稀释,其次为操作过程中的随机效应。结论选择检定合格的仪器,提高操作技能,可有效减小实验的不确定度。

Objective To evaluate the uncertainty of the determination of oxaliplatin in Oxaliplatin and Mannitol Injection by HPLC - external standard method. Methods According to the relevant provisions in Evaluation and Expression of Uncertainty in Measurement（ JJFI059- 1999 ） , the uncertainty of the determination of oxaliplatin in the Oxaliplatin and Mannitol Injection was evaluted. Results The expanded uncertainty was 1.14% and the determination results can be expressed as （ 95.9±1.2）%. The main source of the uncertainty were the balance weighing and the dilution of solution, followed by the random effects in the opera- tion. Conclusion The selection of certified apparatus and improvement of operating skills can effectively reduce the uncertainty.