HPLC法测定炔诺酮片含量及含量均匀度的不确定度分析

Analysis of the Uncertainty of the Content and the Content Uniformity in HPLC Determination of Norethisterone Tablets

目的:建立测定炔诺酮片含量及含量均匀度不确定度的分析方法。方法:采用高效液相色谱法测定含量及建立含量均匀度的数学模型,确定影响不确定度的因素并对各个不确定度因素进行评估。结果:炔诺酮片含量和含量均匀度测定的合成不确定度均为1.2%,扩展不确定度均为2.4%,结果分别为(101.8±2.4)%、(102.3±2.4)%。结论:本方法可用于该制剂含量及含量均匀度的不确定度分析。

OBJECTIVE： To establish a method for uncertainty analysis about the content of norethisterone and its content uniformity in HPLC determination of norethisterone tablets. METHODS： The mathematic model of uncertainty measurement was deduced in the procedure of determining the content and content uniformity in norethisterone tablets by HPLC, and the factors influencing the uncertainty were determined and the factors were evaluated. RESULTS： The combined uncertainty of both content and content uniformity were 1.2%; the extended uncertainty of both were 2.4%, and the determined content were （101.8± 2.4） % and （ 102.3± 2.4） % respectively. CONCLUSIONS： This method is applicable for the uncertainty analysis about the content and content uniformity of norethisterone tablets.