HPLC法测定氯霉素阴道软胶囊含量的不确定度分析

Evaluation of Measurement Uncertainty for the Content Determination of Chloramphenicol Vaginal Soft Capsules by HPLC

目的:HPLC法测定氯霉素阴道软胶囊含量的不确定度,分析来源及影响不确定的因素,从而能更好控制实验误差。方法:按照国家药品标准中氯霉素阴道软胶囊含量测定方法通过建立相应数学模型,对实测数据经行分析和处理,量化不确定分量,计算合成不确定度和扩展不确定度,找出影响不确定度的主要因素。结果:计算出扩展不确定U=0.8%(K=2)。结论:对照品浓度和样品装量差异是测量结果产生不确定的主要来源。

Objective:To evaluate the uncertainty of chloramphenicol vaginal soft capsule content by HPLC,analyze the source and influence factors,so as to better control the experimental error.Methods:According to the determination method of chloramphenicol vaginal soft capsule in the national drug standard,the corresponding mathematical model was established,and the measured data was analyzed and processed to quantify the uncertain components.The expended uncertainty was evaluated and combined by each componet of uncertainty.The main factor of uncertainty were finded out.Results:The expanded uncertainty was U=0.8%(K=2).Conclusion:The uncertainty of chloramphenicol vaginal soft capsule by HPLC were mainly caused by load difference of sample and concentration of the reference substance.