The Quality Standard Study On The New Drug Yi Zhi'an

Alzheimer disease(AD) is a neurodegenerative disorder of the central nervous system. It is recognized as public health prolem having a severe impact on human beings.Acetylcholinesterase inhibitors(AChEI) are the most potent and successful drugs for treatment of AD. Yi Zhi'an was studied on by a company of Changchun city. It is a highlyeffective, reversible inhibitor of cholinesterases, it readily crosses the blood-brain barrier and has been shown to inhibit tissue acetylcholinesterase. The process can be easily controlled and is suitable for a scal production.A reversed-phase high-performance liquid chromatographic (HPLC) method has been developed and validated for the impurity test of the novel drug Yi Zhi'an. The process was performed on a C18 column(25 × 4.6mml.D.,particle size 3.5 μm)with acetonitrile-0.05M triethylamine, pH3.0(13:87) was adjusted by formic acid as the mobile phase. The flow-rate was 1.0ml/min and eluent was monitored at 268nm.The chromatographic method is carried out on C18 column using acetonitrile-0.05M triethylamine, pH3.0(13:87) was adjusted by formic acid as the mobile phase., detector being set at 268nm , the linear relation of calibration curve in the range of 0.2-2.0 μgmL-1 was excellent (r = 0.9999) .The average recovery is 100.04 %with RSD = 0.92%.The method is rapid , accurate and reliable for qualitycontrol of Yi Zhi'an. The acid-base non-aqueous titration is also used extensively to control the quality of Yi Zhi'an. Acetic acid was selected as the solvent, and 0.1mol/L perchloric was selected as the standard solution to determine the content of Yi Zhi'an. The average recovery of Yi Zhi'an raw material was 99.3%, RSD was 0.06%. This study showed that acid-base non-aqueous titration was easy to operate and with simple, perfect stability, rapid, accurate. It could be used for controlling the quality of Yi Zhi'an.