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分析了氨茶碱注射液中无水茶碱含量测定过程中含量的重复性测量、样品的取样量、样品的稀释体积和紫外分光光度法的测量等因素对含量测定不确定度的影响。量化了各分量的相对标准不确定度,进而得出合成标准不确定度和扩展不确定度。建立的不确定度评定方法适用于分光光度法测定氨茶碱注射液中无水茶碱含量的不确定度分析。
The analysis of the repeatability of the content of anhydrous theophylline in the aminophylline injection, the sample volume, the diluted volume of the sample and the UV spectrophotometry were used to analyze the influence of the determination of the content on the uncertainty. The relative standard uncertainty of each component is quantified, and the resultant standard uncertainty and extended uncertainty are obtained. The established uncertainty assessment method is suitable for the determination of the uncertainty of anhydrous theophylline content in aminophylline injection by spectrophotometry.