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Compatibility studies of Donepezil with different excipients by using HPLC and FTIR


Prathyusha C H

Abstract

Validation of HPLC method used in the investigation and to determine the possible interactions between Donepezil Hydrochloride and some excipients like microcrystalline cellulose (MCC), sodium starch glycolate (SSG), Mannitol, magnesium sterate (Mg sterate) and talc when stored in elevated temperature. The drug and excipient binary mixtures were evaluated by using HPLC & FTIR KBr pellet method.The HPLC method shows linearity in the range of 2 to20μg/ml with regression of 0.998, %RSD of method precision was found to be 0.510 and %Recovery was found to be101.66. The chromatograms of drug excipient mixtures (stored at 55°C for20 days) results no change in Rt, area and did not show any extra peak when compared with the standard chromatogram. FTIR spectras shows neither missing nor appearance of new peaks when compared with the standard spectra. The drug excipient results of HPLC & FTIR results shows the suitability of Donepezil with selected excipients when stored in elevated temperature conditions.



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