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目的:建立测定泼尼松龙原料药含量的测量不确定度的评定方法。方法:采用高效液相色谱(HPLC)内标法测定泼尼松龙原料药的含量,并建立评定其不确定度的数学模型,分析测量不确定度的影响因素并对各因素进行评估。结果:HPLC内标法测定泼尼松龙原料药含量为98.8%,其扩展测量不确定度为1.6%,测量结果表示为(98.8±1.6)%,k=2。结论:该方法适用于评定HPLC内标法测定泼尼松龙原料药含量的不确定度。
Objective: To establish a method to evaluate the uncertainty of measurement of prednisolone bulk drug substance. Methods: The content of prednisolone was determined by high performance liquid chromatography (HPLC). The mathematical model was established to evaluate the uncertainty of the prednisolone. The influencing factors of the measurement uncertainty were analyzed and the factors were evaluated. Results: The content of prednisolone was 98.8% by HPLC. The extended measurement uncertainty was 1.6%. The measured result was (98.8 ± 1.6)%, k = 2. Conclusion: This method is suitable for assessing the uncertainty of the content of prednisolone by HPLC.