Uncertainty Measurement Evaluation of the Content Determination of Prednisolone API by HPLC
10.6039/j.issn.1001-0408.2015.33.46
- VernacularTitle:HPLC法测定泼尼松龙原料药含量的测量不确定度评定
- Author:
Li QIN
;
Ying XIAO
;
Ying WANG
;
Yagang FAN
- Publication Type:Journal Article
- Keywords:
Prednisolone API;
HPLC internal standard method;
Content determination;
Uncertainty measurement
- From:
China Pharmacy
2015;26(33):4737-4739
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the uncertainty measurement evaluation of the content determination of pred-nisolone API. METHODS:HPLC internal standard method was adopted to determine the content of prednisolone API,establish mathematical model for uncertainty evaluation,analyze influential factors and evaluate the factors. RESULTS:HPLC internal stan-dard method showed the contont was 98.8%,and expanded uncertainty of prednisolone API was 1.6%,and the determination result was(98.8±1.6)%,k=2. CONCLUSIONS:The method is suitable for the uncertainty measurement evaluation of the content deter-mination of prednisolone API by HPLC internal standard method.
