Analysis of the Uncertainty of the Content and the Content Uniformity in HPLC Determination of Norethisterone Tablets / 中国药房

ABSTRACT

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.