电感耦合等离子体原子发射光谱法测定药用缓释材料中锡含量的不确定度评定

Evaluation of uncertainty in determination of tin content in pharmaceutical sustained-release materials by inductively coupled plasma atomic emission spectrometry

对电感耦合等离子体法测定缓释材料中锡含量的测量不确定度进行综合评定。根据《中华人民共和国药典》和JJF 1059.1—2012《测量不确定度评定与表示》,参考ISO/IEC GUIDE 98-4—2012《测量的不确定性第4部分:合格评定中不确定性的测量作用》,对电感耦合等离子体原子发射光谱法测定丙交酯乙交酯共聚物中锡含量过程中的称量、稀释、标准溶液配制、标准曲线拟合等过程进行不确定度分析。标准溶液的配制和标准曲线的拟合是影响电感耦合等离子体原子发射光谱法测定结果的主要因素,在95%的置信区间内,当样品中的锡含量为0.010%时,测量结果为0.010%±0.003%,k=2。

The uncertainty of determination of tin content in sustained-release materials by inductively coupled plasma atomic emission spectrometry was evaluated.According to Chinese Pharmacopoeia and JJF 1059.1—2012,the main sources of uncertainty in determination of tin content in lactide and ethyl ester copolymer were analyzed with reference to ISO/IEC GUIDE 98-4—2012 "Uncertainty in Measurement-Part 4:Measurement Role of Uncertainty in Conformity Assessment".The components of each uncertainty were evaluated scientifically and systematically.The preparation of standard solution and the fitting of standard curve are the main factors affecting the uncertainty of inductively coupled plasma-atomic emission spectrometry method,within the 95% confidence interval,when the tin content of the sample was 0.010%,the measurement result was 0.010%±0.003%,k=2.This method has important reference significance for evaluating the uncertainty of content determination by inductively coupled plasma-atomic emission spectrometry.