HPLC测定氯氮平片含量的测量不确定度评定

Evaluation of Uncertainty for the Determination of Clozapine Tablets by HPLC

摘要: 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。

Abstract: OBJECTIVE To evaluate the measurement uncertainty for the determination of clozapine tablets by HPLC. METHODS The mathematical model of determination by HPLC was established. The uncertainty sources had been analyzed. Each active component of uncertainty was calculated, and the expanded uncertainty was obtained. RESULTS The expanded uncertainty for the HPLC determination of clozapine was 0.9%, and the result of determination was(100.2±0.9)%, k=2. CONCLUSION The main sources of uncertainty are analyzed, which provide the reliable theoretical basis for effectively controlling of this method.