磷酸奥司他韦颗粒含量测定的不确定度评定  

Analysis of Measurement Uncertainty in Determination of Oseltamivir Phosphate in Oseltamivir Phosphate Granules

作　　者：刘肃[1] 苏广海[1] 

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《中国药物评价》2016年第3期129-132,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:建立高效液相色谱(HPLC)法测定磷酸奥司他韦含量的不确定度评价方法。方法:采用HPLC法测定磷酸奥司他韦含量。根据检验过程,建立数学模型,分析影响其不确定度因素来源,对各个不确定度因素进行评定,得出扩展不确定度。结果:本实验的扩展不确定度为U=0.23 mg/袋(k=2)。结论:HPLC法测定磷酸奥司他韦含量结果较为可靠准确,该方法的不确定度主要由对照品称量、稀释过程和测得的色谱峰面积引入,提高上述因素的精确性可以得到更为准确的结果。Objective： To establish a high performance liquid chromatography（ HPLC） method for uncertainty analysis of oseltamivir phosphate in oseltamivir phosphate granules. Methods： HPLC method was established to determinate the content of oseltamivir phosphate in oseltamivir phosphate granules. According to its inspection process,a mathematical model was established to analyze the factors affect uncertainty of oseltamivir phosphate. Each active component of uncertainty was calculated the variable parameters among the procedures. The combined uncertainty and extended uncertainty and confidence were finally obtained by synthesized the uncertainties of various component variables. Results： The expanded measurement uncertainty U = 0. 23 mg / bag（ k = 2）. Conclusion： Determination of content uncertainty of oseltamivir phosphate in oseltamivir phosphate granules by HPLC can lead a rather correct and dispensable result and the uncertainty is mainly gained by weighing reference,the dilution process and measuring chromatographic peak area.

关 键 词：磷酸奥司他韦 颗粒剂 高效液相色谱法 不确定度分析 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]