Volume : 5, Issue : 8, AUG 2019

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DONEPEZIL HCL IN THE PRESENCE OF ITS RELATED COMPOUNDS BY RP - HPLC

A.APARNA*, DR. M. AJITHA, K.S.L. HARIKA

Abstract

A simple, precise, & accurate Rp – HPLC method has been developed & validated for the related compounds of Donepezil Hydrochloride in pellets formation. An gradient separation was achieved using primesil - C18 (150x 4.6mm, 3µ) column with a flow rate of 1ml / min & photo diode array detector at 230nm. The mobile phase is composed of Acetonitrile, water and perchloric acid in the ratio of 300 : 600 :1 with a column oven temperature of 350C. The diluent is composed of methanol and 0.1N HCL in ratio of 3:1 ratio. the method was validated for specificity, linearity, precision, accuracy & robustness. The method was found to be robust & suitable for the quantitative analysis of related substance in a pellet formation. The method is useful for the determination of following impurities Desbenzyl Donepezil and Donepezil NOxide

Keywords

RP – HPLC, DONEPEZIL HYDROCHLORIDE, ACETONITRILE, DESBENZYL DONEPEZIL AND DONEPEZIL N-OXIDE.

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References

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