LC procedure with SPE for quantification of indobufen enantiomers: pharmacokinetic studies

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 22; no. 1; pp. 93 - 100
• Main Author: Główka, Franciszek K
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01-02-2000; Elsevier Science
• Subjects: Analysis; Area Under Curve; Biological and medical sciences; Calibration; Chromatography, High Pressure Liquid; Enantiomers; General pharmacology; Half-Life; Humans; Indobufen; Isoindoles; Man serum concentration; Medical sciences; Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions; Pharmacology. Drug treatments; Phenylbutyrates - analysis; Phenylbutyrates - blood; Phenylbutyrates - pharmacokinetics; Platelet Aggregation Inhibitors - analysis; Platelet Aggregation Inhibitors - blood; Platelet Aggregation Inhibitors - pharmacokinetics; Precolumn derivatization; Racemate; Reproducibility of Results; RP-LC; SPE; Spectrophotometry, Ultraviolet; Stereoisomerism; Man serum concentration; Indobufen; Precolumn derivatization; Racemate; SPE; Enantiomers; RP-LC; Human; Validation; Solid phase extraction; Oral administration; Racemization; Liquid chromatography; Chiral compound; In vitro; Intramuscular administration; Stereoselectivity; In vivo; Ultraviolet detector; Enantiomer; Detection limit; Separation process; Pharmacokinetics; Quantitative analysis
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/S0731-7085(99)00259-9

A rapid and selective liquid chromatography (LC) with solid phase extraction (SPE) to quantify indobufen (INDB) enantiomers is described. The INDB enantiomers and internal standard (racemic flurbiprofen) are extracted from a small volume of acidified serum (0.2 ml) by means of SPE using cartridges with octadecyl chemically bound phase and analysed on reversed phase (RP), C
18 column with ultraviolet detection at 275 nm. Recovery of both INDB enantiomers was in the range 92.1–94.3%. The mobile phase is composed of acetonitrile-potassium dihydrogen phosphate (pH 4.75;10 mM) (38:62, v/v). The linear range of the standards curves was from 0.25 to 25.00 μg ml
−1 in serum for both enantiomers. The limit of quantification and detection for both INDB enantiomers in serum were 0.25 μg ml
−1 (CV≤10%), and 0.1 μg ml
−1, respectively. Both intra- and inter-day accuracy and precision of the calibration curves were determined and their CV values did not exceed 10%. The validated method has been successfully applied for chiral pharmacokinetics studies of INDB from tablets and intramuscular injections in man.