Uncertainty Measurement Evaluation of the Content Determination of Prednisolone API by HPLC / 中国药房

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.