论文部分内容阅读
目的评定HPLC测定氯氮平片含量的测量不确定度。方法建立HPLC测定含量的数学模型,分析测量不确定度的来源并对各分量进行量化分析和评估,合成标准测量不确定度,给出扩展测量不确定度报告。结果 HPLC测定氯氮平片含量的扩展测量不确定度为0.9%,测量结果表示为(100.2±0.9)%,k=2。结论分析产生不确定度的主要来源,为有效地控制该含量测定方法的准确性提供可靠的理论依据。
Objective To assess the uncertainty of measurement of clozapine by HPLC. Methods The mathematical model of HPLC determination of content was established. The sources of measurement uncertainty were analyzed and the components were quantified and evaluated. The standard measurement uncertainty was synthesized and the report of extended measurement uncertainty was given. Results The extended measurement uncertainty for the determination of clozapine by HPLC was 0.9%. The measurement was expressed as (100.2 ± 0.9)%, k = 2. Conclusion The main source of uncertainty is analyzed, which provides a reliable theoretical basis for the effective control of the accuracy of the determination method.