Validation of a sensitive and automated 96-well solid-phase extraction liquid chromatography–tandem mass spectrometry method for the determination of desloratadine and 3-hydroxydesloratadine in human plasma

Yang, Liyu; Clement, Robert P.; Kantesaria, Bhavna; Reyderman, Larisa; Beaudry, Francis; Grandmaison, Charles; Donato, Lorella Di; Massé, Robert; Rudewicz, Patrick J.

doi:10.1016/s1570-0232(03)00267-8

Cited by 39 publications

(37 citation statements)

References 13 publications

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“…Another class of related structures are based on 1-(diphenylmethyl)piperazine, that is, for instance cetirizine, cinnarizine, hydroxyzine, and meclozine. In MS-MS, the bond between the diphenylmethyl part and the piperazine ring is cleaved, with charge retention either on both sides, as shown for cinnarizine , m/z 311, Scheme 25) is extensively studied (e.g., Yang et al, 2003). In MS-MS, desloratadine shows the loss of NH 3 followed by the loss of Cl , and the loss of 29 Da (H 2 C=NH) from the 4-methylenepiperidine ring.…”

Section: B Histamine Antagonistsmentioning

confidence: 99%

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Niessen¹

2011

Mass Spectrometry Reviews

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The identification of drugs and related compounds by LC-MS-MS is an important analytical challenge in several application areas, including clinical and forensic toxicology, doping control analysis, and environmental analysis. Although target-compound based analytical strategies are most frequently applied, at some point the information content of the MS-MS spectra becomes relevant. In this article, the positive-ion MS-MS spectra of a wide variety of drugs and related substances are discussed. Starting point was an MS-MS mass spectral library of toxicologically relevant compounds, available on the internet. The positive-ion MS-MS spectra of ∼570 compounds were interpreted by chemical and therapeutic class, thus involving a wide variety of drug compound classes, such benzodiazepines, beta-blockers, angiotensin-converting enzyme inhibitors, phenothiazines, dihydropyridine calcium channel blockers, diuretics, local anesthetics, vasodilators, as well as various subclasses of anti-diabetic, antidepressant, analgesic, and antihistaminic drugs. In addition, the scientific literature was searched for available MS-MS data of these compound classes and the interpretation thereof. The results of this elaborate study are presented in this article. For each individual compound class, the emphasis is on class-specific fragmentation, as discussing fragmentation of all individual compounds would take far too much space. The recognition of class-specific fragmentation may be quite informative in determining the compound class of a specific unknown, which may further help in the identification. In addition, knowledge on (class-specific) fragmentation may further help in the optimization of the selectivity in targeted analytical approaches of compounds of one particular class.

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Section: B Histamine Antagonistsmentioning

confidence: 99%

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Niessen¹

2011

Mass Spectrometry Reviews

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“…Plasma was separated and frozen to at least -20°C until and shipped frozen with dry ice to the analytical laboratory (PPD Pharmaco, Richmond, Virginia, USA). Plasma samples were then assayed for desloratadine and 3-OH-desloratadine concentrations using liquid chromatography with tandem mass spectrometric detection [9]. The lower limit of quantification (LLOQ) was 0.025 ng ml -1 for both desloratadine and 3-OHdesloratadine.…”

Section: Blood Sampling and Bioanalytical Analysesmentioning

confidence: 99%

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

Gupta¹,

Kantesaria²,

Banfield³

et al. 2007

Brit J Clinical Pharma

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What is already known about this subject • According to recent literature, the pathophysiologies of allergic rhinitis and chronic idiopathic urticaria are thought to be similar in adults and children. In addition, the response to antihistamine treatment is similar in adults and children, suggesting a similar concentration-response relationship.• However, an appropriate dose selection and the pharmacokinetics of desloratadine in children of Ն6 months-Յ2 years old have never been addressed in the literature. What this study adds• This study demonstrated that desloratadine syrup offers a safe treatment option for allergic conditions in young children.• A suitable dose for children aged Ն6 months-<1 year is 1.0 mg, while the corresponding predicted dose for children aged Ն1 year-Յ2 years is 1.25 mg. These paediatric doses yielded similar systemic desloratadine exposures (AUC) to those seen with a typical adult dose of 5.0 mg. AimsThe aim of this study was to identify the dose of desloratadine in children aged Ն6 months-Յ2 years that would yield a single-dose target exposure (AUC) comparable with that in adults taking 5 mg desloratadine as syrup. MethodsIn a phase 1, single-dose, open-label, pharmacokinetic study in 58 children aged Ն6 months-<1 year and Ն1 year-Յ2 years were randomly assigned to desloratadine syrup 0.625 mg (1.25 ml) and 1.25 mg (2.5 ml), respectively. Because the volume of blood that could be collected from individual subjects was limited, a population pharmacokinetic approach was used to estimate the pharmacokinetics of desloratadine. Safety was assessed based on results of screening and postdose physical examinations, laboratory safety tests, vital signs, and adverse events. ResultsThe apparent clearance (CL/F) of desloratadine, population estimate (%CV), in children aged Ն6 months-<1 year was 27.8 l h -1 (35) and corresponding values in children Ն1 year-Յ2 years was 35.5 l h -1 (51), compared with 137 l h -1 (58) for adults. The CL/F ratios (children to adults) indicated that doses of 1 mg for Ն6 months-<1 year and 1.25 mg for Ն1 year-Յ2 years would result in similar systemic exposure to that observed in adults receiving the recommended 5 mg dose. Desloratadine was well tolerated with no safety issues. ConclusionsDoses of 1.0 and 1.25 mg in children aged Ն6 months-Յ2 years should result in an exposure to desloratadine similar to that of adults receiving doses of 5 mg.

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“…The number of applications is now very great [6] and is probably largely undocumented, since most pharmaceutical companies currently use them routinely for almost all small-molecule bioanalysis and do not publish the majority of their methods. A number of recent publications have used LC-UV [7], LC-fluorescence [8,9], GC-MS [10] and LC-MS-MS [11][12][13][14][15][16][17][18][19] systems for analysis and quantification following solid-phase extraction in a 96-well format.…”

Section: Introductionmentioning

confidence: 99%

96-Well solid-phase extraction: a brief history of its development

Venn

Merson

Cole

et al. 2005

Journal of Chromatography B

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Validation of a sensitive and automated 96-well solid-phase extraction liquid chromatography–tandem mass spectrometry method for the determination of desloratadine and 3-hydroxydesloratadine in human plasma

Cited by 39 publications

References 13 publications

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Fragmentation of toxicologically relevant drugs in positive‐ion liquid chromatography–tandem mass spectrometry

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults

96-Well solid-phase extraction: a brief history of its development

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