DEVELOPMENT AND VALIDATION OF A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR BIOANALYTICAL APPLICATION WITH RANITIDINE HCL

摘要

A.simple,.rapid.and.specific.bioanalytical.procedure.was.developed.and.validated.for.the.quantification.of.Ranitidine.HCl.(RHCl).in.human.plasma.by. High‐Performance. Liquid. Chromatography. (HPLC). with. UV. detection.. The. chromatographic. separation. was. achieved. in. a. Cyano. Column.(250mm.x4.6mm;5μm)..The.mobile.phase.was.a.mixture.of.10mM.phosphate.buffer.and.acetonitrile.(50:50,.v/v).at.a.flow.rate.of.1.0.mL.min‐1..The.UV.detection.was.set.at.320.nm.and.0rnidazole.was.used.as.an.internal.standard.(IS)..An.original.pretreatment.procedure.of.plasma.sample. was.developed,.based.on.liquid‐liquid.extraction.with.dichloromethane..The.method.was.validated.over.the.concentration.range.of.50.ng.mL‐1.to.2000.ng.mL‐1.for.Ranitidine.HCl.in.human.plasma.with.correlation.coefficient.of.0.9985.The.limit.of.detection(LOD).was.5.ng.mL‐1..In.stability.tests,.RHCl.in. human. plasma. was. stable. during. storage. and. assay. procedure.. The. method. was. very. rapid,. simple,. sensitive. and. economical,. and. was.successfully.applied.to.human.pharmacokinetic.study