紫外分光光度法测定头孢拉定胶囊含量的不确定度评价  

Estimation of uncertainty for content determination of cefradine capsules by ultraviolet spectrophotometry

作　　者：常艳[1] 姚尚辰[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国抗生素杂志》2007年第8期472-477,共6页Chinese Journal of Antibiotics

摘　　要：目的对紫外分光光度法测定制剂含量的不确定度进行评定。方法以头孢拉定胶囊为例,建立紫外分光光度法测定头孢拉定胶囊含量的不确定度计算模型,对紫外分光光度法测定中的各影响因素进行了考察。结果量化了各分量的相对标准不确定度,并计算出合成标准不确定度,取κ=2(置信概率95%)得出扩展不确定度。结论在现有条件下使测定结果受控,并可通过分析各分量的相对标准不确定度的大小来优化实验,使测定结果更加可靠。Objective To estimate of uncertainty on the content determination of cefradine capsules by ultraviolet spectrophotometry. Method The model for evaluation of the uncertainty was established in measurement of the content of cefradine capsules by ultraviolet spectrophotometry. The factors influenced upon the measurement were analyzed and the uncertainty influence of each component was calculated. Result The combined standard uncertainty was obtained by combining all standard uncertainty, then the expanded uncertainty was calculated by using a coverage factor κ = 2 with a confidence level of approximately 95%. Conclusion To make the measurement under control, the more reliable result of the measurement could be obtained when the measure was optimized by magnitude analysis all standard uncertainty.

关 键 词：头孢拉定 紫外分光光度法 不确定度 方法评价 

分 类 号：R927.2[医药卫生—药学]