Stereoselective analysis of nebivolol isomers in human plasma by high-performance liquid chromatography–tandem mass spectrometry: Application in pharmacokinetics

Neves, Daniel Valente; Vieira, Carolina Pinto; Coelho, Eduardo Barbosa; Marques, Maria Paula; Lanchote, Vera Lúcia

doi:10.1016/j.jchromb.2013.09.031

Cited by 11 publications

(8 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Our method employed a simple liquid-liquid extraction procedure for both analytes, since protein precipitation offers minimal selectivity and SPE is usually much more expensive, complex and time consuming. (Neves et al, 2013;Chen et al, 2015). However, a stereoselective analysis would not be relevant to our purpose in the present study.…”

Section: Discussionmentioning

confidence: 92%

“…Although a better choice of IS for nebivolol would be a stable isotope‐labeled analog (instead of tramadol), no significant matrix effect was observed, as previously mentioned. Finally, since nebivolol is marketed as a racemic mixture of d ‐ and l ‐isomers, some other studies employed chiral columns (Neves et al, ; Chen et al, ). However, a stereoselective analysis would not be relevant to our purpose in the present study.…”

Section: Discussionmentioning

confidence: 99%

“…Hydrochlorothiazide has been used in the pharmacological treatment of hypertension for more than five decades and, thus, a very large Protein precipitation, liquid-liquid extraction and SPE have been employed for sample preparation. The run time ranges from 2.0 min (Ramakrishna et al, 2005) to >10.0 min (Neves, Vieira, Coelho, Marques & Lanchote, 2013). All methods employ ESI and the LOQ ranges from 0.01 ng/mL (Selvan et al, 2007) to 0.51 ng/mL (Venkateswarlu et al, 2014).…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Bioequivalence study between a fixed‐dose single‐pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high‐performance liquid chromatography coupled to tandem mass spectrometry

Vespasiano

Laurito

Iwamoto

et al. 2016

Biomedical Chromatography

View full text Add to dashboard Cite

Systemic arterial hypertension is a major risk factor for cerebrovascular disease. Therefore, adequate control of blood pressure is of enormous importance. One of the many fixed-dose single-pill antihypertensive formulations available on the market is the combination of nebivolol and hydrochlorothiazide. The objective of this study was to develop two distinct high-performance liquid chromatography coupled to tandem mass spectrometry methods to simultaneously quantify nebivolol and hydrochlorothiazide in human plasma. The methods were employed in a bioequivalence study, the first assay involving a nebivolol fixed-dose single-pill formulation based on healthy Brazilian volunteers. Nebilet HCT™ (nebivolol 5 mg + hydrochlorothiazide 12.5 mg tablet, manufactured by Menarini) was the test formulation. The reference formulations were Nebilet™ (nebivolol 5 mg tablet, manufactured by Menarini) and Clorana™ (hydrochlorothiazide 25 mg tablet, manufactured by Sanofi). For both analytes, liquid-liquid extraction was employed for sample preparation and the chromatographic run time was 3.5 min. The limits of quantification validated were 0.02 ng/mL for nebivolol and 1 ng/mL for hydrochlorothiazide. Since the 90% CI for C , AUC and AUC individual test/reference ratios were within the 80-125% interval indicative of bioequivalence, it was concluded that Nebilet HCT™ is bioequivalent to Nebilet™ and Clorana™.

show abstract

Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Bioequivalence study between a fixed‐dose single‐pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high‐performance liquid chromatography coupled to tandem mass spectrometry

Vespasiano

Laurito

Iwamoto

et al. 2016

Biomedical Chromatography

View full text Add to dashboard Cite

show abstract

“…Chiral stationary phase Chirobiotic T and polar mobile phase (methanol/acetic acid/triethylamine) were employed in the pharmacokinetic studies of carvedilol [134] and acebutolol [135]. Chiral stationary phase containing vancomycin (Chirobiotic V) demonstrated efficiency in enantioseparation of atenolol, labetalol, and nebivolol [127,136,137].…”

Section: Stereoselective Analytical Methods In the Study Of Pharmacokmentioning

confidence: 99%

Survey of Pharmacological Activity and Pharmacokinetics of Selected β-Adrenergic Blockers in Regard to Their Stereochemistry

et al. 2019

View full text Add to dashboard Cite

The present survey concentrates on pharmacodynamics and pharmacokinetics of selected β-adrenergic blockers from the point of view of their stereochemistry. It could be shown that the activity in the arylaminoethanol and aryloxyaminopropanol group of β-blockers is higher in their (–)-enantiomers as compared with the (+)-enantiomers. The stereoisomers differ also in other types of bioactivity as well as in toxicity. The particular pharmacokinetic stages such as resorption, distribution, and metabolism are discussed in regard to their stereochemistry.

show abstract

“…Nebivolol causes vasodilation through stimulation of the endothelial L-arginine-nitric oxide pathway (Prisant, 2008). For its determination only LC/MS/MS methods were previously described (Nandania, Rajput, Contractor, Vasava, Solanki, & Vohra, 2013;Neves, 2013;Ramakrishna et al, 2005).…”

Section: Bisoprolol Chemically (Rs)-1-{4-[(2-isopropoxyethoxy)methyl]mentioning

confidence: 99%

Fast and sensitive analysis of beta blockers by ultra‐high‐performance liquid chromatography coupled with ultra‐high‐resolution TOF mass spectrometry

Tomková

Ondra

Kociánová

et al. 2017

Biomedical Chromatography

View full text Add to dashboard Cite

This paper presents a method for the determination of acebutolol, betaxolol, bisoprolol, metoprolol, nebivolol and sotalol in human serum by liquid-liquid extraction and ultra-high-performance liquid chromatography coupled with ultra-high-resolution TOF mass spectrometry. After liquid-liquid extraction, beta blockers were separated on a reverse-phase analytical column (Acclaim RS 120; 100 × 2.1 mm, 2.2 μm). The total run time was 6 min for each sample. Linearity, limit of detection, limit of quantification, matrix effects, specificity, precision, accuracy, recovery and sample stability were evaluated. The method was successfully applied to the therapeutic drug monitoring of 108 patients with hypertension. This method was also used for determination of beta blockers in 33 intoxicated patients.

show abstract

Stereoselective analysis of nebivolol isomers in human plasma by high-performance liquid chromatography–tandem mass spectrometry: Application in pharmacokinetics

Cited by 11 publications

References 10 publications

Bioequivalence study between a fixed‐dose single‐pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high‐performance liquid chromatography coupled to tandem mass spectrometry

Bioequivalence study between a fixed‐dose single‐pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high‐performance liquid chromatography coupled to tandem mass spectrometry

Survey of Pharmacological Activity and Pharmacokinetics of Selected β-Adrenergic Blockers in Regard to Their Stereochemistry

Fast and sensitive analysis of beta blockers by ultra‐high‐performance liquid chromatography coupled with ultra‐high‐resolution TOF mass spectrometry

Contact Info

Product

Resources

About