Development, validation and analytical error function of two chromatographic methods with fluorimetric detection for the determination of bisoprolol and metoprolol in human plasma

Abstract

This work describes two high-performance liquid chromatographic methods for the individual determination of bisoprolol and metoprolol in human plasma. Analytical methods involve two different liquid-liquid extractions of human plasma, with diethyl ether for bisoprolol and with dichloromethane for metoprolol, coupled with a similar Nucleosil C(18) reversed-phase HPLC column. Fluorimetric detection was used to identify both beta-blockers. Retention times for bisoprolol and metoprolol were 8.7 and 3.2 min, respectively. Linear regressions for the calibration curves were linear at a concentration range of 6.25-200 ng/mL. Intra- and inter-day precision coefficients of variations and accuracy bias were acceptable (within 15%) over the entire range for both drugs. Average recovery was 89% for metoprolol and 98% for bisoprolol. Once the methods had been validated, analytical error functions were established as standard deviation (SD; ng/mL) = 2.216 + 3.608 x 10(-4)C(2) (C = theoretical concentration value) and SD-(ng/mL) = 0.408 + 0.378 x 10(-1)C for bisoprolol and metoprolol, respectively. The methods developed and their associated analytical error functions will be suitable for pharmacokinetic studies and for determination of plasma concentration if posology individualization of these drugs is needed.

HPLC quantification of metoprolol with solid-phase extraction for the drug monitoring of pediatric patients

“…Most of these methods involve relatively laborious and tedious liquidliquid extraction (Persson et al, 1990;Braza et al, 2002) before HPLC analysis. Other methods differentiate between the enantiomers (Bhatti and Foster, 1992;Mistry et al, 2001), because the metabolism is enantioselective.…”

Development and Validation of TLC-Densitometry Method for Simultaneous Estimation of Bisoprolol Fumarate and Hydrochlorothiazide in Bulk and Tablets

“…Literature survey reveals, many analytical methods such as HPLC [3,4], TLC-densitometry [5], fluorimetric determination [6], LC-MS [7], enantioanalysis human plasma [8] for estimation of BF in pharmaceutical formulation and biological fluids. Various analytical methods such as HPLC [9][10][11][12], differential pulse voltameter [13], stability indicating determination [14], photometric determination of HCTZ [15] were reported.…”

Liquid chromatography tandem mass spectrometry method for determination of bisoprolol in human plasma using d5‐bisoprolol as the internal standard

“…These HPLC methods have usually adopted a liquid-liquid extraction procedure which involves tedious drying and reconstitution processes and which requires a large sample volume. All of these features may seriously restrict application of these published methods to rapid and highthroughput bioanalytical assays (Taguchi et al, 2005;Braza et al, 2002;Eastwood et al, 1990;Liu et al, 2007;Ding et al, 2007;Jovanovic et al, 2006). Other methods have used solid-phase extraction for sample preparation, which gives the advantage of reducing interference from the matrix, but it may be costineff ective compared with other procedures (Horikiri et al, 1998;Caudron et al, 2004;Bhatt et al, 2007;Kristoff ersen et al, 2007;Maurer et al, 2004).…”

“…It also signifi cantly reduces morbidity and mortality in stable chronic heart failure patients (Ishiguro et al, 2008;De Groote et al, 2007;Metra et al, 2007). Several previous reports have described the determination of bisoprolol in plasma using analytical methods including HPLC-FL (Taguchi et al, 2005;Braza et al, 2002;Eastwood et al, 1990;Horikiri et al, 1998), HPLC-DAD (Caudron et al, 2004), GC-MS (Shangguan et al, 2008) and LC-MS/MS Ding et al, 2007;Jovanovic et al, 2006;Bhatt et al, 2007;Kristoff ersen et al, 2007;Maurer et al, 2004). These HPLC methods have usually adopted a liquid-liquid extraction procedure which involves tedious drying and reconstitution processes and which requires a large sample volume.…”