The Quality Study Of EBTp & Hydroxynovoldiamine

Drug quality control is one of the main contents of innovative drug research and development,and is an important means to guarantee the purity of drugs.The development of drug analysis methods is the basis for controlling drug quality.Scientific and reasonable analysis methods can not only accurately monitor the reactions of the entire synthetic process of the drug,but also play a role in the study of the accurate quantification of drugs,influencing factors,and other investigation items in the formulation of quality standards,thereby ensuring the quality and safety of drugs and Reliable,ensure the safety of medications for listed drugs.Therefore,the research of analytical methods in drug quality control has great practical significance for the research and development of innovative drugs.This article reviews the application of chromatography,especially high performance liquid chromatography,in drug discovery and research.According to the guidelines of the 2015 edition of the Chinese Pharmacopoeia and related drug quality research,quality studies were hydroxynovoldiamine,it was a key intermediate of anti-inflammatory drug hydroxychloroquiine and the antitumor drug EBTp.The development of analytical methods,influencing factors,validation of relevant material methods,content determination methods,etc.were completed in the EBTp quality study.In the study of the quality of the hydroxynovoldiamine,the gas phase analysis method of the hydroxynovoldiamine was determined according to the structural properties of the compound and verified by specificity,linearity,detection limit,accuracy,etc.This method is scientific,accurate,and reasonable.The content of this study provides a basis for the development of quality standards for EBTp and can be used for the monitoring of impurities in the synthesis of hydroxynovoldiamine.