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目的:建立以HPLC法测定头孢氨苄胶囊含量的测量不确定度评定方法。方法:通过对各分量的分析,计算各分量的不确定度,最后计算出合成标准不确定度uc和扩展不确定度U95。结果:头孢氨苄胶囊含量测定的结果可表示为:101.7%±3.26%(k=2),uc为1.63%,U95为3.26%。结论:本文所建立的方法可用于该制剂含量的不确定度的评定。
Objective: To establish a method for the determination of the uncertainty of the determination of cephalexin capsules by HPLC. Methods: Through the analysis of each component, calculate the uncertainty of each component, and finally calculate the composite standard uncertainty uc and extended uncertainty U95. Results: The results of determination of cephalexin capsules can be expressed as: 101.7% ± 3.26% (k = 2), uc 1.63%, U95 3.26%. Conclusion: The method established in this paper can be used to assess the uncertainty of the content of the preparation.