title: A Wide Linearity Range Method for the Determination of Lenalidomide in Plasma by High-Performance Liquid Chromatography: Application to Pharmacokinetic Studies.
abstract: A wide linearity range analytical method for the determination of lenalidomide in patients with multiple myeloma for pharmacokinetic studies is required. Plasma samples were ultrasonicated for protein precipitation. A solid-phase extraction was performed. The eluted samples were evaporated to dryness under vacuum, and the solid obtained was diluted and injected into the high-performance liquid chromatography (HPLC) system. Separation of lenalidomide was performed on an Xterra RP C18 (250 mm length × 4.6 mm i.d., 5 µm) using a mobile phase consisting of phosphate buffer/acetonitrile (85:15, v/v, pH 3.2) at a flow rate of 0.5 mL · min-1The samples were monitored at a wavelength of 311 nm. A linear relationship with good correlation coefficient (r = 0.997, n = 9) was found between the peak area and lenalidomide concentrations in the range of 100 to 950 ng · mL-1The limits of detection and quantitation were 28 and 100 ng · mL-1, respectively. The intra- and interassay precisions were satisfactory, and the accuracy of the method was proved. In conclusion, the proposed method is suitable for the accurate quantification of lenalidomide in human plasma with a wide linear range, from 100 to 950 ng · mL-1This is a valuable method for pharmacokinetic studies of lenalidomide in human subjects.
authors.affiliation: Pharmacy Department, Doctor Peset University Hospital of Valencia, Valencia, Spain guglieri_bea@gva.es.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Guglieri-López
authors.affiliation: Pharmacy Department, University Clinical Hospital of Valencia, Valencia, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Pérez-Pitarch
authors.affiliation: Pharmacy Department, Doctor Peset University Hospital of Valencia, Valencia, Spain.
authors.forename: Maria Amparo
authors.initials: MA
authors.lastname: Martinez-Gómez
authors.affiliation: Pharmacy Department, Doctor Peset University Hospital of Valencia, Valencia, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Porta-Oltra
authors.affiliation: Pharmacy Department, Doctor Peset University Hospital of Valencia, Valencia, Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: Climente-Martí
authors.affiliation: Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Valencia, Molecular Recognition and Technological Development Institute, Centro Mixto Universidad Politécnica de Valencia-Universidad de Valencia, Valencia, Spain.
authors.forename: Matilde
authors.initials: M
authors.lastname: Merino-Sanjuán
mesh_terms: D020533:Angiogenesis Inhibitors / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D000077269:Lenalidomide; D010949:Plasma / Q000737:chemistry*; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D020533:Angiogenesis Inhibitors; D013792:Thalidomide; D000077269:Lenalidomide
keywords: high-performance liquid chromatography; human plasma; lenalidomide; monitoring; pharmacokinetic studies; therapeutic drug