Analysis of the Uncertainty of the Content and the Content Uniformity in HPLC Determination of Norethisterone Tablets
- VernacularTitle:HPLC法测定炔诺酮片含量及含量均匀度的不确定度分析
- Author:
Li SUN
- Publication Type:Journal Article
- Keywords:
Uncertainty;
HPLC;
Content;
Content uniformity;
Norethisterone
- From:
China Pharmacy
1991;0(04):-
- CountryChina
- Language:Chinese
-
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.
