Quality analysis for the domestic dosage form of indometacin suppositories

Objective:To evaluate the quality status of domestic dosage form of indometacin suppositories.Methods: According to the general requirements of national assessment programs in 2010 use statutory testing methods and combine with the exploratory research to examine sample,evaluate the quality status of domestic dosage form of indometacin suppositories.Results: In this paper,we proved that the HPLC method of ChP is simple,by comparing the investigation of specificity and results of related substance between BP and ChP.We confirm that the two major impurities come from synthetic process of material.We find that domestic dosage form and import dosage form are different through the dissolution test of USA,because the domestic dosage form is fat-solubility suppository and the import dosage form is water-solubility suppository.Conclusions: At present the products quality of indometacin suppositories can meet the current standards.The exploratory research suggests that we can control the impurities of material to increase the quality of dosage.