HPLC测定米诺地尔搽剂中米诺地尔含量的不确定度评定OA
Uncertainty Evaluation for Determination of Minoxidil Content in Minoxidil Liniment by HPLC
目的:建立米诺地尔搽剂中米诺地尔含量检测结果的不确定度评定方法.方法:建立测量模型,分析测量过程中不确定度的来源以及各因素对含量检测结果的影响,评估各不确定度分量,确定米诺地尔含量检测结果的扩展不确定度.结果:HPLC法测定米诺地尔搽剂中米诺地尔含量的合成相对标准不确定度为2.46 ×10-2,合成不确定度为2.51％,扩展不确定度为5.02％,米诺地尔含量的检测结果为(101.96±5.02)％.结论:本方法可用于HPLC法测定米诺地尔搽剂中米诺地尔含量的不确定度分析,使检测结果更加可靠.
Objective:To establish a method for evaluating the uncertainty of determination of minoxidil content in Minoxidil liniment.Methods:The measurement model was established.The source of uncertainty and the influence of various factors on the measurement results were analyzed,and the components of uncertainty were evaluated to determine the extended uncertainty of minoxidil content results.Results:The combined relative standard uncertainty of minoxidil content in Minoxidil liniment by HPLC was 2.46 × 10-2,and the combined uncertainty was 2.51％.The extended uncertainty was 5.02％,and the determination result of minoxidil content was(101.96±5.02)％.Conclusion:The method can be used for the uncertain analysis of minoxidil content in Minoxidil liniment by HPLC,and the determination results are more reliable.
丰杰;郭文琪;张元杰;祖桂芳;王明姣;鞠英杰
北京诺博特生物科技有限公司质量管理部,北京 102299北京诺博特生物科技有限公司质量管理部,北京 102299北京诺博特生物科技有限公司质量管理部,北京 102299北京诺博特生物科技有限公司质量管理部,北京 102299北京诺博特生物科技有限公司质量管理部,北京 102299北京诺博特生物科技有限公司质量管理部,北京 102299
中医学
米诺地尔搽剂米诺地尔含量高效液相色谱法不确定度
Minoxidil linimentMinoxidilContent determinationHigh performance liquid chromatography(HPLC)Uncertainty
《中国药物评价》 2025 (2)
102-106,5
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