A new simple, accurate, sensitive and specific bioanalytical spectrofluorimetric method was developed and validated for quantitative determination of donepezil hydrochloride (DH) in human plasma. Estimation of DH in human plasma was done by spiked human plasma studies. Forestimation of DH in human plasma extraction was carried out using 5% TCA forprotein precipitation followed by liquid-liquid extraction with 5% IPA in n-Hexane.Under spectrofluorimetric conditions delta value 65 applied in synchronous mode(medium sensitivity mode) and wavelength used in analysis was 389 nm. Developed method found linear, in the concentration range of 50-105 ng/mL with correlation coefficient (R2) 0.9965. Percentage recovery was found to be 75 %-85 %for DH. High recovery show that the method is free from the interference from plasma constituents. Hence proposed method can be used for estimation of DH in routine quality control laboratories for quantitative determination of DH in bulk as well as in human plasma. Further it can also be used to determine plasma DH concentration in drug monitoring or in pharmacokinetic investigations.
Key words : Bioanalytical method, Donepezil hydrochloride, Human plasma, Synchronous spectrofluorimetry.