Pharmacokinetic evaluation of daclatasvir and ledipasvir in healthy volunteers using a validated highly sensitive spectrofluorimetric method
| Autor: | Amira S. Gouda, Ola M. Abdallah, Ahmed M. Abdel-Megied |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Ledipasvir
Analyte Pyrrolidines Daclatasvir Biophysics Standard solution 030226 pharmacology & pharmacy 01 natural sciences 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Pharmacokinetics Healthy volunteers medicine Humans Fluorenes Chromatography Molecular Structure Chemistry 010401 analytical chemistry Imidazoles Valine Healthy Volunteers 0104 chemical sciences Highly sensitive Fluorescence intensity Spectrometry Fluorescence Chemistry (miscellaneous) Benzimidazoles Carbamates Tablets medicine.drug |
| Zdroj: | Luminescence. 33:1094-1100 |
| ISSN: | 1522-7235 |
| DOI: | 10.1002/bio.3514 |
| Popis: | 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 λem 384 nm after excitation at λex 318 nm for DAC and in acetonitrile at λem 402 nm after excitation at λex 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. |
| Databáze: | OpenAIRE |
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