| 引用本文: | 秦立,王莹,张利,范亚刚.HPLC测定氯氮平片含量的测量不确定度评定[J].中国现代应用药学,2015,32(2):189-194. |
| QIN Li,WANG Ying,ZHANG Li,FAN Yagang.Evaluation of Uncertainty for the Determination of Clozapine Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(2):189-194. |
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| 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。 |
| 关键词: 测量不确定度 高效液相色谱法 氯氮平片 |
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| Evaluation of Uncertainty for the Determination of Clozapine Tablets by HPLC |
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QIN Li, WANG Ying, ZHANG Li, FAN Yagang
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Yunnan Provincial Institute for Food and Drug Control, Kunming 650011, China
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| 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. |
| Key words: measurement uncertainty HPLC clozapine tablets |
