LC-UV method to assay raloxifene hydrochloride in rat plasma and its application to a pharmacokinetic study

  • Márcia Camponogara Fontana Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia
  • João Víctor Laureano Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia
  • Betielli Forgearini Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia
  • Paula dos Santos Chaves Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia
  • Bibiana Verlindo de Araujo Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia
  • Ruy Carlos Ruver Beck Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia https://orcid.org/0000-0001-6262-1097
Keywords: Raloxifene/pharmacokinetic, Liquid chromatography, Plasma, Bioavailability

Abstract

A specific, precise, and accurate LC-UV method was developed and validated to assay raloxifene hydrochloride in rat plasma. Raloxifene was analyzed after liquid-liquid extraction and quantified by reversed phase liquid chromatography (C18 column) using acetonitrile and ammonium acetate buffer 0.05 M (pH 4.0) as mobile phase at a flow rate of 1 mL.min-1 and UV detection at 287 nm. Retention times of raloxifene and internal standard (dexamethasone) were approximately 11 min and 14 min, respectively. Linearity was checked for a concentration range between 25 ng.mL-1 and 1000 ng.mL-1. Intra- and inter-day precision had relative standard deviation lower than 10% and 15%, respectively. Recovery from plasma was higher than 90%. Accuracy values were 98.21%, 99.70%, and 102.70% for lower, medium, and upper limits of quantification, respectively. Limit of quantification was 25 ng.mL-1. Drug stability was analyzed at room temperature using plasma kept in a freezer at -80 °C for 45 days after processing for 6 h and three freeze-thaw cycles. The advantages of the method developed include stability under different conditions and low limit of quantification. Its applicability was confirmed by the analysis of raloxifene levels in plasma samples in a designed pharmacokinetic study in rats after intravenous administration (5 mg.kg-1).

Downloads

Download data is not yet available.
Published
2019-12-04
How to Cite
Fontana, M., Laureano, J. V., Forgearini, B., Chaves, P., Araujo, B., & Beck, R. C. (2019). LC-UV method to assay raloxifene hydrochloride in rat plasma and its application to a pharmacokinetic study. Brazilian Journal of Pharmaceutical Sciences, 55, e18052. https://doi.org/10.1590/s2175-97902019000118052
Section
Articles