Large-volume injection of sample diluents not miscible with the mobile phase as an alternative approach in sample preparation for bioanalysis: An application for fenspiride bioequivalence

Bioanalysis

Volumn 3, Issue 17, 2011, Pages 1935-1947

  Medvedovici, Andrei ^a,b   Udrescu, Stefan ^b   Albu, Florin ^b   Tache, Florentin ^a   David, Victor ^a  

^a UNIVERSITY OF BUCHAREST   (Romania)

^b LaborMed Pharma SA   (Romania)

Author keywords

[No Author keywords available]

Indexed keywords

ACETONITRILE; DILUENT; FENSPIRIDE; OCTANOL; TRIMETAZIDINE;

ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SOLUBILITY; ELECTROSPRAY; ELUTION; HUMAN; HUMAN EXPERIMENT; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PARTICLE SIZE; RANDOMIZED CONTROLLED TRIAL; REVERSED PHASE LIQUID CHROMATOGRAPHY; SINGLE DRUG DOSE; STANDARD; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; MASS SPECTROMETRY; REPRODUCIBILITY OF RESULTS; SPIRO COMPOUNDS; THERAPEUTIC EQUIVALENCY;

EID: 80052811770     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.148     Document Type: Article

References (21)

1. Snyder LR, Kirkland JJ, Dolan JW. Introduction to Modern Liquid Chromatography. (3rd Ed.). J. Wiley & Sons, Inc., NJ, USA 69-74; 253-303; 403-475 (2010).
2. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. Wiley, NY, USA (1988).
3. Dolan JW. Broad peaks. LC-GC North Am. 22, 26-30 (2004).
4. Pedersen K, Dolan JW. A picture is worth a thousand words. LC-GC Europe 24(2), 72-76 (2011).
5. Keunchkarian S, Reta M, Romero L et al. Effect of sample solvent on the chromatographic peak shape of analytes eluted under reversed-phase liquid chromatographic conditions. J. Chromatogr. A 1119(1-2), 20-28 (2006). (Pubitemid 43831903)
6. Castells CB, Castells RC. Peak distortion in reversed-phase liquid chromatography as a consequence of viscosity differences between sample solvent and mobile phase. J. Chromatogr. A 805(1-2), 55-61 (1998). (Pubitemid 28231186)
7. Cherrak D, Guernet E, Cardot P et al. Viscous fingering: a systematic study of viscosity effects in methanol-isopropanol systems. Chromatographia 46(11-12), 647-654 (1997). (Pubitemid 27514348)
8. Snyder LR, Dolan JW. High Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model. 188-195; John Wiley & Sons, Inc., NJ, USA (2007).
9. Loeser E, Drumm P. Using strong injection solvents with 100% aqueous mobile phase in RPLC. J. Sep. Sci. 29(18), 2847-2852 (2006). (Pubitemid 46075524)
10. Medvedovici A, Vasile D, Victor D et al. Retention phenomena induced by large-volume injection of solvents non-miscible with the mobile phase in reversed-phase liquid chromatography. J. Liq. Chromatogr. Relat. Technol. 30(2), 199-213 (2007). (Pubitemid 44950964)
11. Udrescu S, Medvedovici A, David V. Effect of large-volume injection of hydrophobic solvents on the retention of less hydrophobic pharmaceutical solutes in RP-LC. J. Sep. Sci. 31, 2939-2945 (2008).
12. David V, Barcutean C, Georgita C et al. Non-miscible solvent large-volume injection - PLC-DAD method for determination of butylated hydroxyanisole in lovastatin and simvastatin pharmaceutical formulations. Rev. Roum. Chim. 5, 445-451 (2006).
13. Udrescu S, Sora ID, David V et al. Large-volume injection of hexane solutions in RPLC-UV to enhance on sensitivity of the assay of ginkgolic acids in Ginkgo Biloba standardized extracts. J. Liq. Chromatogr. Relat. Technol. 33(1), 133-149 (2010).
14. Loeser E, Babiak S, Drumm P. Water-immiscible solvents as diluents in reversed-phase liquid chromatography, J. Chromatogr. A. 1216(15), 3409-3412 (2009).
15. Udrescu S, Sora ID, Albu F et al. Large-volume injection of 1-octanol as sample diluent in reversed-phase liquid chromatography: application in bioanalysis for assaying of indapamide in whole blood. J. Pharm. Biomed. Anal. 54(5), 1163-1172 (2011).
16. Montes B, Catalan M, Roces A et al. Single dose pharmacokinetics of fenspiride hydrochloride: phase I clinical trial. Eur. J. Clinical. Pharmacol. 45(2), 169-172 (1993). (Pubitemid 23267423)
17. Janniot JP, Chezaubernard C. Pharmacokinetic properties of fenspiride: an update. Eur. Resp. Rev. 1, 101-104 (1991).
18. Sauveur C, Baune A, Vergnes N et al. Quantitative determination of fenspiride in human plasma and urine by liquid chromatography with electrochemical or ultraviolet detection. J. Pharm. Biomed. Anal. 7(12), 1799-1804 (1989). (Pubitemid 20253613)
19. Dumasia MC, Houghton E, Hyde W et al. Detection of fenspiride and identification of in vivo metabolites in horse body fluids by capillary gas chromatography-mass spectrometry: administration, biotransformation and urinary excretion after a single oral dose. J. Chromatogr. B 767(1), 131-144 (2002). (Pubitemid 34142344)
20. Guideline on Validation of Bioanalytical Methods. European Medicines Agency EMEA/CPMP/ EWP/19221 (2009).
21. Lytle FE, Julian RK, Tabert AM. Incurred sample reanalysis: enhancing the Bland- Altman approach with tolerance intervals. Bioanalysis 1(4), 705-714 (2009).