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Pharmacokinetic evaluation of daclatasvir and ledipasvir in healthy volunteers using a validated highly sensitive spectrofluorimetric method
Author(s) -
Abdallah Ola M.,
AbdelMegied Ahmed M.,
Gouda Amira S.
Publication year - 2018
Publication title -
luminescence
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.428
H-Index - 45
eISSN - 1522-7243
pISSN - 1522-7235
DOI - 10.1002/bio.3514
Subject(s) - daclatasvir , analyte , chromatography , pharmacokinetics , ledipasvir , methanol , chemistry , extraction (chemistry) , detection limit , acetonitrile , food and drug administration , fluorescence , analytical chemistry (journal) , pharmacology , medicine , biochemistry , physics , organic chemistry , quantum mechanics , genotype , gene , ribavirin
A simple, highly sensitive and selective spectrofluorimetric method has been developed and fully validated for the determination of daclatasvir (DAC) and ledipasvir (LED) in tablets and human plasma. The method is based on measurement of the native fluorescence in methanol at λ em 384 nm after excitation at λ ex 318 nm for DAC and in acetonitrile at λ em 402 nm after excitation at λ ex 340 nm for LED. The fluorescence intensity (FI) concentration plot was rectilinear over the ranges 1.2–12, 0.1–18 ng ml −1 and 9–90, 1–100 ng ml −1 with a good correlation of r = 0.9994 to r = 0.9997 in standard solution and human plasma for DAC and LED, respectively. The extraction of analytes from plasma was performed using methanol and acetonitrile as a precipitating agent with lower limit of quantification (LLOQ) of 0.1 and 1.0 ng ml −1 for DAC and LED; respectively. The proposed method was validated according to the US Food and Drug Administration (FDA) guidelines and successfully applied for estimating the pharmacokinetic parameters of DAC and LED following oral administrations of their tablets.