HPLC测定小儿氨酚匹林片含量的不确定度评价

Evaluation of Uncertainty for Determination of Pediatric Aspirin and Paracetamol Tablets by HPLC

目的对小儿氨酚匹林片中阿司匹林、对乙酰氨基酚的含量进行不确定度评价。方法建立评价高效液相色谱法测定小儿氨酚匹林片含量不确定度的数学模型,对测定中的各影响因素进行考察。结果阿司匹林、对乙酰氨基酚的扩展不确定度分别为1.4%、1.2%,相对扩展不确定度分别为1.5%、1.2%,含量测定结果分别为(91.7±1.4)%、(98.1±1.2)%。结论供试品溶液峰面积是定量分析的测量不确定度的主要因素。

OBJECTIVE To evaluate uncertainty in measures of the content of pediatric aspirin and paracetamol tablets. METHODS The model for evaluation of the uncertainty was established based on the measures of content of pediatric aspirin and paracetamol tablets by HPLC. The factors influenced upon the measuration were analysed. RESULTS The relative expanded uncertainty U95 of pediatric and paracetamol was 1. 4% , 1. 2% and the related expanded uncertainty Ur,,l was 1. 5% , 1. 2% , respectively. The result of content determination of pediatric and paracetamol was （91.7 ± 1.4）% , （98.1 ±1. 2）%. CONCLUSION The peak area of sample was the primary factor for the measurement uncertainty.