Achiral–chiral LC/LC–FLD coupling for determination of carvedilol in plasma samples for bioequivalence purposes

Rapid and Sensitive Carvedilol Assay in Human Plasma Using a High-Performance Liquid Chromatography with Mass/Mass Spectrometer Detection Employed for a Bioequivalence Study

“…Usually, such procedure allows higher recoveries for the target compounds, as the solubility in the supernatant is enhanced by the organic solvent [11]. The recoveries of carvedilol and the IS were assessed by analyzing three sets of standards at three concentrations (5, 20 and 100 ng/ml).…”

“…Carvedilol has been quantified in biological fluids using high-performance liquid chromatography (HPLC) with fluorescence [1][2][6][7][8][9][10][11] or electrochemical detector [12], mass spectrometry [13][14][15], hydrophilic interaction liquid chromatography (HILIC) with tandem mass spectrometry [16], capillary electrophoresis-ultra violet detector [17] and gas chromatography (GC)-MS detector [18]. The clean-up procedures for the extraction of carvedilol from biological matrix has been carried out by protein precipitation [8][9]13,15], solid-phase extraction (SPE) [2,6,12], liquid-liquid extraction (LLE) [10,14,18], combinations of protein precipitation with SPE [7] or combinations of LLE with back-extraction [1,11].…”

“…The clean-up procedures for the extraction of carvedilol from biological matrix has been carried out by protein precipitation [8][9]13,15], solid-phase extraction (SPE) [2,6,12], liquid-liquid extraction (LLE) [10,14,18], combinations of protein precipitation with SPE [7] or combinations of LLE with back-extraction [1,11]. However, these methods used a large volume of biological fluids (0.15-1.0 ml plasma or 2-5 ml urine), time-consuming pre-treat procedures for LLE, SPE or derivatization steps and required a long run-time (20 min) to obtain high sensitivity.…”

Assessment of bioequivalence of drug racemates: what are the cues from a bioanalytical perspective—stereoselective vs nonstereoselective?

“…The analytical literature is flooded with an increasing number of reports on enantioselective separation and quantitation of chiral drugs (Medvedovici et al, 2007;Siluk et al, 2007;Alves et al, 2007;Maraschiello et al, 2006;Trivedi et al, 2007;Di Pietro et al, 2006;Srinivas, 2004a,b;Marzo and Heftmann, 2002). It has now become standard practice to employ chiral assays in the earliest life cycle of NCE discovery/development.…”

HPLC Method Development and Validation of S(-)-Carvedilol from API and Formulations

“…Direct methods involve the use of chiral stationary-phase columns or mobile phases containing chiral additives. Different columns such as Phenomenex 3022 (Torrance, CA) [14], Chiralpak AD (Daicel Chemical Industries, Tokyo, Japan) [15], and Chiralcel OD-RH (Chiral Technologies Europe, France) [16] coupled to an HPLC system with fluorescence detection have been described for the analysis of Carvedilol enantiomers in plasma. Capillary electrophoresis using hydroxypropyl-beta-cyclodextrin as chiral selector has also been used for the enantioselective analysis of Carvedilol in serum using ultraviolet detector [17], or laser-induced fluorescence detector [18].…”