A high throughput and sensitive liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the estimation of bisoprolol in human plasma using multiplexing technique

Bhatt, Jignesh; Subbaiah, Gunta; Kambli, Sandeep; Shah, Bhavin; Patel, Mehul; Saxena, Ashish; Baliga, Ashok; Nigam, Samita; Parekh, Hetal; Yadav, Gunvat

doi:10.1016/j.jchromb.2007.01.043

Cited by 32 publications

(14 citation statements)

References 10 publications

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“…The bioanalysis was performed in compliance with the principles of Good Laboratory Practice in the Pharmacology Department of the Pharmaceutical Research Institute, Warsaw. The applied bioanalytical method included slight modifications to the previous reports [6,10,11]. Reference standards of bisoprolol fumarate and metoprolol tartrate (the internal standard [IS]), were purchased from USP and Sigma-Aldrich (St. Louis, MO, USA), respectively.…”

Section: Bioanalysismentioning

confidence: 99%

Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers

et al. 2017

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A b s t r a c tBackground: Bisoprolol is one of the most widely used beta-blockers characterised by cardioselectivity, and it has no intrinsic sympathomimetic activity. It is commonly used in the treatment of coronary heart disease and heart failure. Aim:The aim of study was to assess the bioequivalence of the film-coated tablets containing 2.5 mg of bisoprolol (Bisocard ® -the medicinal product) to the original medicinal product (Concor Cor 2.5 ® -the reference). Methods:A randomised, open-label, two-period, crossover, single-dose, relative bioavailability study was conducted in fasted healthy Caucasian volunteers. A single 10-mg oral dose (four tablets of 2.5 mg) of the test or reference product was followed by a 14-day wash-out period, after which the subjects received the alternative product. Blood was sampled within a period of 60 h post administration in pre-specified time points. Bisoprolol concentrations were determined by a validated LC-MS/MS method. The products were considered bioequivalent if the 90% confidence interval (CI) of the log-transformed geometric mean ratios (test vs. reference) for AUC (0-t) , AUC (0-∞) , and C max were within 80-125% limits. Adverse events were monitored during the study based on the subject claims and clinical parameters.Results: Twenty-six healthy male and female volunteers (mean age ca. 29 years; body mass index 22.7 kg/m 2 ) were included in the study, and 24 completed the clinical part. The geometric mean ratios (test/reference) for the log-transformed AUC (0-t) , AUC (0-∞) , and C max were 95.16% (90% CI 92.52-97.87%), 95.08% (90% CI 92.40-97.83%), and 100.00% (90% CI 94.83-105.45%), respectively. There were no significant differences in the pharmacokinetic parameters between the test and reference formulations. No serious adverse events were reported. Conclusions:The results of this single-dose study in healthy Caucasian volunteers indicate that Bisocard ® ; 2.5 mg film-coated tablets are bioequivalent to the reference product -Concor Cor 2.5 ® ; 2.5 mg film-coated tablets. Both products had similar safety profile and have been well tolerated.

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Section: Bioanalysismentioning

confidence: 99%

Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers

et al. 2017

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“…The human plasma sample containing the selected medicine and internal standard was processed using Oasis HLB extraction cartridge, then eluted with acetonitrile. The recovery of bisoprolol was 93.98% with an accuracy of 4.46% [17]. To extract (S)-(-) and (R)-(+)-metoprolol the LiChrosep DVB HL extraction cartridge employing 200 μL of human plasma was used.…”

Section: Solid Phase Extractionmentioning

confidence: 99%

“…These methods include liquid chromatography coupled with mass spectrometry (LC-MS/MS) [7][8][9][10][11][12][13][14][15][16][17], liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS/MS) [18,19], gas chromatography coupled with mass spectrometry (GC-MS) [3,[20][21][22], high performance liquid chromatography (HPLC) [23,24], high performance liquid chromatography coupled with mass spectrometry (HPLC-MS) [25,26], high performance liquid chromatography with fluorescence detection (HPLC-FLD) [2,27,28], high performance liquid chromatography coupled with ultraviolet detection (HPLC-UV) [29], reversed-phase ultra-high-performance liquid chromatography coupled with mass spectrometry (UHPLC-MS) [30].…”

Section: Introductionmentioning

confidence: 99%

Preparation of Biological Samples Containing Metoprolol and Bisoprolol for Applying Methods for Quantitative Analysis

Corina¹,

Hăncianu²,

Agoroaei³

et al. 2015

Acta Medica Marisiensis

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Arterial hypertension is a complex disease with many serious complications, representing a leading cause of mortality. Selective beta-blockers such as metoprolol and bisoprolol are frequently used in the management of hypertension. Numerous analytical methods have been developed for the determination of these substances in biological fluids, such as liquid chromatography coupled with mass spectrometry, gas chromatography coupled with mass spectrometry, high performance liquid chromatography. Due to the complex composition of biological fluids a biological sample pre-treatment before the use of the method for quantitative determination is required in order to remove proteins and potential interferences. The most commonly used methods for processing biological samples containing metoprolol and bisoprolol were identified through a thorough literature search using PubMed, ScienceDirect, and Willey Journals databases. Articles published between years 2005-2015 were reviewed. Protein precipitation, liquid-liquid extraction and solid phase extraction are the main techniques for the extraction of these drugs from plasma, serum, whole blood and urine samples. In addition, numerous other techniques have been developed for the preparation of biological samples, such as dispersive liquid-liquid microextraction, carrier-mediated liquid phase microextraction, hollow fiber-protected liquid phase microextraction, on-line molecularly imprinted solid phase extraction. The analysis of metoprolol and bisoprolol in human plasma, urine and other biological fluids provides important information in clinical and toxicological trials, thus requiring the application of appropriate extraction techniques for the detection of these antihypertensive substances at nanogram and picogram levels.

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“…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.…”

Section: Introductionmentioning

confidence: 99%

“…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). In a previously published paper, we have reported a validated LC-MS/MS method for the determination of 10 antiarrhythmic drugs and a metabolite in human plasma (Li et al, 2007).…”

Section: Introductionmentioning

confidence: 99%

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

Liu

Wang

Jia

et al. 2009

Biomedical Chromatography

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A simple, reliable and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) protocol was developed and validated for quantification of bisoprolol in human plasma. The sample was pretreated with a simple procedure of protein precipitation and an isotope-labeled d5-bisoprolol was used as internal standard. The chromatographic separation was performed on a Capcell Pak C(18) MG III column (100 mm x 2.0 mm, 5 microm). The protonated ion of the analyte was detected in positive ionization by multiple reaction monitoring mode. The mass transition pairs of m/z 326.3 --> 116.3 and m/z 331.3 --> 121.3 were used to detect bisoprolol and the internal standard, respectively. Linearity, accuracy, precision, recovery, matrix effect, dilution test and stability were evaluated during method validation over the range of 0.5-100 ng/mL. The validated method was successfully applied to analyze human plasma samples in a bisoprolol bioavailability study.

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A high throughput and sensitive liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the estimation of bisoprolol in human plasma using multiplexing technique

Cited by 32 publications

References 10 publications

Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers

Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers

Preparation of Biological Samples Containing Metoprolol and Bisoprolol for Applying Methods for Quantitative Analysis

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

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