SIMULTANEOUS UV-SPECTROPHOTOMETRIC ESTIMATION OF ROSUVASTATIN AND EZETIMIBE IN THEIR COMBINED DOSAGE FORMS

摘要

Rosuvastatin.is.an.HMG.Co‐A.inhibitor.and.Ezetimibe.is.an.intestinal.cholesterol.absorption.inhibitor..The.combination. formulation. is. used. for. the. treatment. of. hypercholestrolemia..Three.new,.simple,.accurate.and. precise. UV. spectrophotometric. methods. have. been. developed. and.validated.for.the.simultaneous.determination. of.Rosuvastatin. (RSV). and. Ezetimibe. (EZE).in. their. combined. dosage.forms.. First. method.is. based. on. Q‐absorption. Ratio. method. using. two. wavelengths,. 232.4. nm. (λmax.of.EZE).and.237.nm.(Isoabsorptive.point)...The.second.method.is.the.dual.wavelength.method,.where.226.4.nm.and.239.2.nm.were. selected. as. λ1.and.λ2.for.the.determination.of.Rosuvastatin.and.232.6.nm.and.252.4.nm. were.selected. similarly.for. the. determination. of. Ezetimibe.. The. last. method. involves. the. use. of. First. order.derivative. technique.. Here. 232.4. nm,. the. zero. crossing. point. of.Ezetimibe,.was.selected.for.the.determination.of.Rosuvastatin.and.223.4.nm,.the.zero.crossing.point.of.Rosuvastatin,.was.selected.for.the.determination.of.Ezetimibe..Methanol.was.the.solvent.used.in.all. three. methods.. Both. drugs. showed.linearity.in.the.range.of.1‐25μg/mL.in.all.the.methods..All.methods. were. validated. statistically. and.recovery.studies.were.carried.out..All.methods.were.found.to.be.accurate,.precise.and.reproducible..These.methods.were.applied.to.the. assay. of. the.drugs. in.marketed.formulation,.which.were.found.in.the.range.of. 98.0%.to.102.0%.of. the.labeled. value.for.both. Rosuvastatin.and.Ezetimibe..Hence,.the.methods.herein.described.can.be.successfully.applied.in.quality.control.of.combined.pharmaceutical.dosage.forms