Abstract:
OBJECTIVE To inspect the consistency of dissolution of sertraline hydrochloride tablets from 8 manufacturers with the original manufacturer, and probe into the rationality of Chinese Pharmacopoeia method.
METHODS Evaluated the similarity of dissolution of sertraline hydrochloride tablets from 8 manufacturers and original manufacturer by the similarity factor(
f2) within 0.1 mol·L
-1 hydrochloride acid(pH=1.2), acetic acid-natrium aceticum buffer solution(pH=4.5), phosphate buffer solution(pH=6.8) and water as medium, respectively by the dissolution chromatographic condition from Chinese Pharmacopoeia.
RESULTS The stripping curves of the 8 manufacturers tablets were not quite similar with that of the original manufacturer, and it showed that the prescription and production process of each manufacturer were different. The drug dissolution was more than 85% in the condition of pH=4.5 medium and 75 r·min
-1.
CONCLUSION By comparing the dissolution curves of different media and calculating
f2, there is a big difference between generic drugs and original agents. It is suggested that enterprises improve the process. At the same time, the dissolution conditions of the Chinese Pharmacopoeia need to be discussed. It is suggested that the Pharmacopoeia Commission revise the speed or limit by referring to the standards of foreign pharmacopoeia.