ComParison on the Process monitoring of dissolution of NifediPine Tablets in two conditions

LIN Gui-ru; XIONG Bin

Abstract：Objective To compare the dissolution results of Nifedipine Tablets in the condition according to Chinese Pharmacopoeia and Japanese OranGe Book respectively,and to provide a scientific basis for quality control and dissolution e-valuation of the products. Methods The dissolution of 6 lots of commercial Nifedipine Tablets randomly selected from dif-ferent manufacturers were determined with a fiber — optic medicine dissolution∕ release rate process monitoring system,and the results determined in the condition according to Chinese Pharmacopoeia and that according to Japanese OranGe Book were comparatively analyzed. Results The dissolution of samples from 6 manufacturers can all reach more than 75% in 60 min in Ch. P. condition,which met the requirements of Ch. P. ,but there was difference in the dissolution behavior of them. When determined in condition according to Japanese OranGe Book,the dissolution of these samples were less than 70% in 30 min,and can not reach dissolution platform in 60 min,which did not meet the requirements of Japanese standard. Con—clusion There was significant difference in the dissolution of Nifedipine Tablets determined in the two conditions. The quality of products from 6 manufacturers were uneven. The dissolution condition from Chinese Pharmacopoeia were more re-laxed than that from Japanese OranGe Book.