Quality Study And Quality Control Of Resperidone Tablets

Risperidone tablets is one of a new generation antipsychotic medications that is used to treat Schizophrenia. It is indicated for acute and chronic schizophrenic psychoses and other psychotic conditions with positive and negative symptoms. Resperidone tablet was developed by Janssen Pharmaceutical Belgium and at present, Xian Janssen Pharmaceutical Ltd. Is the unique manufacturer of this product in China. This medication is more effective and it has fewer side effects than standard anti-psychotic medication. It can improve the quality of patients'life.In order to bring the patients product with high quality, The manufacturer should be responsible to set up a scientific quality standard system to guarantee the product being under a good quality control system. The detailed study on the historical data has been carried out and the purpose of it is to find the scientific analytical methods to conquer the defects of the current analytical methods.In this paper, a HPLC method was described and it was developed to quantitatively determine Resperidone assay and content uniformity tablets as well as to detect degradation compounds in Resperidone. Another HPLC was also developed here to determine the dissolution of Resperidone tablets. Both the two methods were validated based on the ICH guideline and the results shown us the good specificity, accuracy, precision, repeatability and rubstness. Meanwhile they are very easy to operate and popularize, thus they are very useful for the routine determination of Resperidone tablets.