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HPLC法测定复方酮康唑软膏中酮康唑含量的不确定度评定
引用本文:叶杰胜,孙莉. HPLC法测定复方酮康唑软膏中酮康唑含量的不确定度评定[J]. 安徽医药, 2011, 15(10): 1216-1218
作者姓名:叶杰胜  孙莉
作者单位:安徽省芜湖市食品药品检验所,安徽,芜湖,241000;安徽省芜湖市食品药品检验所,安徽,芜湖,241000
摘    要:目的建立HPLC法测定复方酮康唑软膏中酮康唑含量不确定度的评定方法。方法通过建立HPLC含量测定法的数学模型,确定影响不确定度的因素,并对各不确定度因素进行评估。结果复方酮康唑软膏中酮康唑含量测定的合成不确定度为0.3%;扩展不确定度为0.6%;测定结果为(96.5±0.6)%。结论该方法可用于HPLC法测定复方酮康唑软膏中酮康唑含量的不确定度评估。

关 键 词:不确定度  HPLC法  复方酮康唑软膏  酮康唑

Evaluation of uncertainty for the determination of ketoconazole in compound ketoconazole cream by HPLC
YE Jie-sheng,SUN Li. Evaluation of uncertainty for the determination of ketoconazole in compound ketoconazole cream by HPLC[J]. Anhui Medical and Pharmaceutical Journal, 2011, 15(10): 1216-1218
Authors:YE Jie-sheng  SUN Li
Affiliation:(Wuhu Institute for Food & Drug Control,Wuhu 241000,China)
Abstract:Aim To establish a method of uncertainty evaluation for the determination of ketoconazole in compound ketoconazole cream by HPLC.Methods The calculation formula of uncertainty was deduced in the procedure of determining the content in ointments Results The combined uncertainty was 0.3%,the extended uncertainty was 0.6%,and the determined content was(96.5±0.6)%.Conclusion This method is appropriate to be used in the uncertainty evaluation for the determination of ketoconazole in compound ketoconazole cream by HPLC.
Keywords:uncertainty  HPLC  compound ketoconazole cream  ketoconazole
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