SEARCH FOR SIMPLE MOBILE PHASES IN RAPID LC SEPARATIONS-ANALYSIS OF DRUGS IN COMPLEX MATRIX (DICLOFENAC GEL AND INJECTIONS)

摘要

A.novel,.simple,.rapid.RP‐HPLC.method.was.developed.for.analysis.of.Diclofenac.Diethylamine.in.Gel.formulation..The.same.method.was.also.used.for. injectable. formulations..Unlike. the. existing.methods,. the. proposed.method.selects. the. mobile.phase.excluding. buffer.. Use. of.buffer.not. only.emerges.with.time.consuming.process.but.also.makes.the.method.more.expensive.along.with.reducing.the.column.longitivity..The.present.article.is.devoid.of.all.the.referred.problems,.It.has.selected.a.mobile.phase.consisting.of.methanol.:.acetonitrile.(.80.:.20.)v/v..which.gives..a.retention.time..of.2.453.min.and.2.467.min.respectively.for.Diclofenac.gel.and.injection..The.elution.was.carried.out.isocratically.at.flow.rate.of.1.ml./.min..detected.at.λ. max.. of. 284. nm. ..The. limits.of.detection. and. limit.of.. quantification.. were. .13.994. and. 42.408.μg/ml.respectively..The. intraday. and.interday.precision.(measured.by.coefficient.of.variation,.COV%).was.always.less.than..2.0%.with..S.D..less.than.1.0..The.accuracy.(measured.by.relative.error.%).was.always.less.than.1%..The.other.validation.parameters.were.performed.and.calculated.statistically.as.per.ICH.guidelines