紫外分光光度法测定西沙必利片含量的不确定度分析

Analysis of Measurement Uncertainty in the Content Determination of Cisapride Tablets with UV Spectrophotometry

目的:对紫外分光光度法测定西沙必利片含量测量的不确定度进行评定分析,以期找到影响不确定度的因素。方法:按照测量步骤,根据《测量不确定度评定与表示》中的有关规定,评估对照品和样品称量和稀释、对照品的响应因子、紫外仪器等的相对不确定度的影响,计算合成不确定度和扩展不确定度。结果:量化了各不确定度分量,其中以对照品称量和紫外仪器的相对不确定度分量值最高,合成不确定度为0.00958,扩展不确定度为1.92%。结论:西沙必利片含量的紫外测定方法中以紫外仪器测定与对照品称量过程对测定结果不确定度的影响较大。

OBJECTIVE： To analyze the measurement uncertainty in the content determination of Cisapride tablets with UV spectrophotometry, and to find out the influencing factors. METHODS： In accordance with measured steps and the provision of Evaluation and Expression of Uncertainty in Measurement, the effects of relative uncertainty for the weighing and dilution of substance control and test sample, response factor of substance control and relative uncertainty of UV instrument were evaluated, and the composed and expanded uncertainty were calculated. RESULTS： The measurement uncertainties were quantified, among which relative uncertainty for the weighing of substance control and UV instrument were the highest. Composed uncertainty was 0.009 58 and expanded uncertainty was 1.92 %. CONCLUSION： UV instrument and the weighing of substance control greatly influence measurement uncertainty in UV spectrophotometry for the content determination of Cisapride tablets.