ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DONEPEZIL HYDROCHLORIDE TABLETS BY RP-HPLC

摘要

A.simple,.rapid.and.precise.RP‐HPLC.method.has.been.developed.for.the.determination.of.donepezil.hydrochloride.in.bulk.and.tablets..Separation.was.achieved.with.a.keystone.phenyl.RP.250.×.4.6.mm.i.d.,.5.μM.particle.size.analytical.column.using.mixture.of.methanol,.0.02M.phosphate.Buffer.(pH.7.5.±.0.1).and.triethylamine.in.the.ratio.60:.40:.0.5.v/v.as.the.mobile.phase.by.Reverse.phase.isocratic.mode..The.instrumental.settings.are.at.a.flow.rate.of.1mL/min,.column.temperature.at.40°C.and.UV.detection.at.268.nm..The.retention.time.was.found.to.be.7.05.min..The.correlation.coefficient,.RSD.and.tailing.factor.were.found.to.be.0.9970,.0.002275.and.1.11.respectively..The.percentage.contents.found.by.the.proposed.method.were. 100.14,.100.1.and.100.32.mg.in.three.different.brands.. The.proposed.method.can.be.used.for.the.quantification.of.donepezil.hydrochloride.over.linearity.in.the.range.of.50‐150.μg/ml.and.the.mean.percentage.recovery.was.found.to.be.100.37%..The.intra.day.and.inter.day.precision.were.found.0.2034%.and.0.2062.%.respectively..This.method.can.be.used.for.clinical.routine‐monitoring/.in.vitro.metabolism.studies.and.