Back to Search
Start Over
Enantioselective HPLC-DAD method for the determination of etodolac enantiomers in tablets, human plasma and application to comparative pharmacokinetic study of both enantiomers after a single oral dose to twelve healthy volunteers
- Source :
- Talanta. 130:506-517
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- An enantioselective high performance liquid chromatographic method with diode array detection (HPLC-DAD) was developed and validated for the determination of etodolac enantiomers in tablets and human plasma. Enantiomeric separation was achieved on a Kromasil Cellucoat chiral column (250 mm × 4.6mm i.d., 5 µm particle size) using a mobile phase consisting of hexane: isopropanol: triflouroacetic acid (90:10:0.1 v/v/v) at a flow rate of 1.0 mL min(-1). The chromatographic system enables the separation of the two enantiomers and the internal standard within a cycle time of 8 min. The resolution between the two enantiomers was 4.25 and the resolution between each enantiomer and the internal standard was more than 2.0. Detection was carried out at 274 nm, and the purity assessment was performed using a photodiode array detector. Solid phase extraction technique using C-18 cartridge was applied to extract the analytes from the plasma samples, and the percentage recovery was more than 95% for the lower quantification limit. The method has been validated with respect to selectivity, linearity, accuracy and precision, robustness, limit of detection and limit of quantification. The validation acceptance criteria were met in all cases. The linearity range for the determination of each enantiomer in human plasma was 0.4-30.0 µg mL(-1) and the limits of quantification of R-etodolac and S-etodolac were 0.20 and 0.19 µg mL(-1), respectively. The validated method was successfully applied to the determination of etodolac enantiomers in tablets and to a comparative pharmacokinetic study of the two enantiomers after the administration of 300 mg single oral dose etodolac racemate tablets to twelve healthy volunteers.
- Subjects :
- Male
Accuracy and precision
Analyte
Resolution (mass spectrometry)
Administration, Oral
Analytical Chemistry
Plasma
Young Adult
Pharmacokinetics
medicine
Humans
Tissue Distribution
Solid phase extraction
Etodolac
Chromatography, High Pressure Liquid
Detection limit
Chromatography
Molecular Structure
Chemistry
Solid Phase Extraction
Stereoisomerism
Healthy Volunteers
Models, Chemical
Enantiomer
Tablets
medicine.drug
Subjects
Details
- ISSN :
- 00399140
- Volume :
- 130
- Database :
- OpenAIRE
- Journal :
- Talanta
- Accession number :
- edsair.doi.dedup.....ca1d8bd300de520365c028accdbe5a31