Quality Research And Stability Study Of Donepezil Hydrochloride Disintegrating Tablets

In this study,the full quality research of Donepezil Hydrochloride Disintegrating Tablets was conducted.The quality controlled method was developed based on the specification and analytical procedure of this product listed in the USP,and the methodology validation was performed.In addition,the validation batch of Donepezil Hydrochloride Disintegrating Tablets(batch number for 5 mg include 12120501,13012101 and13012102,batch number for 10 mg include 12120502,13012201,13012202),manufactured by Zhejiang Hisun Pharmaceutical Co.,Ltd.(Thereinafter referred as Hisun Pharm)was tested,including related substance,water content,disintegrating time,microbial limit,assay and so forth,compared with RLD drug regarding to the quality consistency,which was manufactured by Japanese Eisai co.,Ltd(Strength 5mg batch number is 11B12 M,Strength 10 mg batch number 15B58M).The result showed that the Donepezil Hydrochloride Disintegrating Tablets,manufactured by Hisun Pharma,is consistent with the one manufactured by Japanese Eisai Co.,Ltd.After sufficient study,the quality standard of Donepezil Hydrochloride Disintegrating Tablets manufactured by Hisun Pharm was established.After the establishment of quality standard,the stability study of Donepezil Hydrochloride Disintegrating Tablets was performed according to the appendix of Chinese Pharmacopoeia,including stress testing,accelerated and long-term testing.The result of stress testing showed that there is no obvious change in assay,dissolution after five days and ten days of light illumination,high temperature(60℃)and high humidity(RH 75%and 92%);The total Donepezil oxide and impurity for Donepezil Hydrochloride Disintegrating Tablets 5 mg was increased slightly within specification,other specified impurity and unspecified impurity were not increased obviously.The specified impurity and total impurity for Donepezil Hydrochloride Disintegrating Tablets 10 mg were not increased obviously;On the other hand,After five days and ten days in the environment of high temperature(60℃),brown spot or black spot were produced in Donepezil Hydrochloride Disintegrating Tablets 5 mg by coking sucralose at high temperature,which can not influence the quality of drug.The result for the sixth month of accelerated stability study demonstrated that nitrogen oxide and total impurity were out of specification with moisture being increased slightly.In conclusion,nitrogen oxide,total impurity and moisture were increased slightly within specification,other test item meet acceptance criteria without obvious change.