title: Development and validation of a spectrofluorimetric method for the determination of erlotinib in spiked human plasma.
abstract: A rapid and sensitive spectrofluorimetric method was developed and validated for the determination of erlotinib (ETB), a potent anticancer drug, in spiked human plasma without any derivatization. The described method was validated and the analytical parameters of linearity, accuracy, precision (intra- and inter-day), limit of detection (LOD), and limit of quantification (LOQ) were evaluated. The relation between the fluorescence intensity and concentration was found to be linear (r(2) 0.9998) over the range 125 to 1000 ng/mL with the detection limit of 15 ng/mL. A simple liquid-liquid extraction method was followed in order to extract the drug from spiked plasma. The mean absolute recoveries of ETB were 85.59 % (±0.57), 86.91 % (±1.77) and 89.31 % (±3.01) at spiked plasma ETB concentration of 5000, 3750 and 2500 ng/mL, respectively. The spectrofluorimetric method presented here is a rapid, simple, specific, and reproducible method and can be used to characterize the plasma pharmacokinetics of ETB.
authors.affiliation: Plough Center for Sterile Drug Delivery Systems, Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN 38163, USA.
authors.forename: Bivash
authors.initials: B
authors.lastname: Mandal
authors.forename: Pavan
authors.initials: P
authors.lastname: Balabathula
authors.forename: Nivesh
authors.initials: N
authors.lastname: Mittal
authors.forename: George C
authors.initials: GC
authors.lastname: Wood
authors.forename: Himanshu
authors.initials: H
authors.lastname: Bhattacharjee
mesh_terms: D000970:Antineoplastic Agents / Q000097:blood* / Q000737:chemistry; D001774:Blood Chemical Analysis / Q000379:methods*; D000069347:Erlotinib Hydrochloride; D006801:Humans; D011799:Quinazolines / Q000097:blood* / Q000737:chemistry; D013050:Spectrometry, Fluorescence / Q000379:methods*; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride