利培酮是新一代的非典型抗精神病藥，對精神分裂癥有良好療效，不良反應(yīng)小。為了便于利培酮的質(zhì)量控制研究，歸納對比國家標(biāo)準(zhǔn)、美國藥典、歐洲藥典、英國藥典所規(guī)定的質(zhì)量標(biāo)準(zhǔn)；并綜述了近年來國內(nèi)外文獻中使用色譜方法分析利培酮原料藥及其制劑的測定及有關(guān)物質(zhì)，包括高效液相色譜法、高效毛細管電泳法、薄層色譜掃描法等。此外，重點總結(jié)了各國藥典對利培酮原料藥及其制劑中各種有關(guān)物質(zhì)的限度規(guī)定，為利培酮有關(guān)物質(zhì)的研究提供了參考與借鑒。

Risperidone is one of the promising atypical antipsychotic drugs, which is effective in the treatment of schizophrenia with few side effects. In order to facilitate the research on Risperidone, the quality standards of Risperidone in Chinese Standard, USP, EP and BP are compared. Besides, the determination methods of related substances and content in Risperidone and its pharmaceutical preparations in recent years were reviewed, including high performance liquid chromatography (HPLC), high performance capillary electrophoresis (HPCE), and thin layer chromatography scanning (TLCs). Furthermore, the limits of impurities in Risperidone and its pharmaceutical preparations are generalized, providing a reference for the research on related substances in Risperidone.