Ultra-sensitive determination of Formoterol in human serum by high performance liquid chromatography and electrospray tandem mass spectrometry

Mascher, Daniel; Zech, K.; Nave, Ruediger; Kubesch, Klaus Michael; Mascher, Hermann

doi:10.1016/j.jchromb.2005.10.022

Cited by 9 publications

(9 citation statements)

References 13 publications

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“…Plasma concentrations of budesonide and formoterol were determined with previously reported methods [25,26] using validated HPLC-MS/MS (HPLC: Aglient 1200 series, Agilent Technologies, Santa Clara, CA, USA; MS/MS: 4000 Qtrap, Applied Biosystems/MDS SCIEX, Framingham, MA, USA) suited in precision, accuracy, and stability during analytics. The lower limits of quantification of formoterol and budesonide were 1 pg·mL −1 , and 100 pg·mL −1 , respectively.…”

Section: Sampling Time and Analysismentioning

confidence: 99%

Exposure-Response and Clinical Outcome Modeling of Inhaled Budesonide/Formoterol Combination in Asthma Patients

et al. 2020

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Exposure-response and clinical outcome (CO) model for inhaled budesonide/formoterol was developed to quantify the relationship among pharmacokinetics (PK), pharmacodynamics (PD) and CO of the drugs and evaluate the covariate effect on model parameters. Sputum eosinophils cationic proteins (ECP) and forced expiratory volume (FEV1) were selected as PD markers and asthma control score was used as a clinical outcome. One-and two-compartment models were used to describe the PK of budesonide and formoterol, respectively. The indirect response model (IDR) was used to describe the PD effect for ECP and FEV1. In addition, the symptomatic effect on the disease progression model for CO was connected with IDR on each PD response. The slope for the effect of ECP and FEV1 to disease progression were estimated as 0.00008 and 0.644, respectively. Total five covariates (ex. ADRB2 genotype etc.) were searched using a stepwise covariate modeling method, however, there was no significant covariate effect. The results from the simulation study were showed that a 1 puff b.i.d. had a comparable effect of asthma control with a 2 puff b.i.d. As a result, the 1 puff b.i.d. of combination drug could be suggested as a standardized dose to minimize the side effects and obtain desired control of disease compared to the 2 puff b.i.d.Pharmaceutics 2020, 12, 336 2 of 16 asthma have been steadily rising, with the patients' burden increasing by around 30% over the past two decades [2][3][4]. It is a complex disease that can be caused by various factors including genetic backgrounds, and has numerous risk factors such as allergens and irritants from the surrounding environment [4]. The rise in prevalence has been related to the recent changes in the lifestyle, which increases exposure to the environmental triggers and it has become a disease that affects almost all populations worldwide [2].Due to the heterogeneity in the clinical and mechanistic characteristics of asthma, efficient prevention and treatment strategies have proven to be challenging to develop [4,5]. A combination of corticosteroids and β 2 -adrenergic agonists are commonly used to relieve the symptoms of the disease (such as, dyspnea, and bronchospasm) [2,6]. Inhaled corticosteroids can suppress the inflammatory reactions, thereby alleviating levels of eosinophils and other inflammatory factors including eosinophils cationic proteins (ECP), which is one of the major inflammatory biomarkers in asthma [4,[6][7][8]. Obstruction of the airways can be relieved and pulmonary function can be increased after inhalation of β 2 -adrenergic agonists, which constrict the smooth muscles of the bronchi. Short-acting β 2 -adrenergic agonists (SABA) are commonly used for a quick relief of acute symptoms, and long-acting β 2 -adrenergic agonists (LABA) are mainly for long-term control of the disease [4,6,9] During the past decade, the management strategies of asthma have seen a gradual change from alleviating acute symptoms to achieving a more constant control of the disease [10]. According to the G...

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Section: Sampling Time and Analysismentioning

confidence: 99%

Exposure-Response and Clinical Outcome Modeling of Inhaled Budesonide/Formoterol Combination in Asthma Patients

et al. 2020

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“…Formoterol fumarate is an official drug in Indian Pharmacopoeia [3] and British Pharmacopoeia [4]. Formoterol fumarate was determined in bulk, pharmaceutical dosage forms, human plasma, serum and urine and rat plasma [5][6][7][8][9][10][11][12][13][14][15][16][17][18]. The techniques for the determination of formoterol fumarate include UV spectrophotometry [5], visible spectrophotometry [6,7], HPLC with UV detection [8][9][10], HPLC with electrochemical detection [11], HPTLC [12], HPLC-MS/MS [13][14][15], capillary electrophoresis [16,17], differential-pulse [18] and square-wave voltammetry [18].…”

Section: Simultaneous Quantification Of Formoterol Fumarate and Glycomentioning

confidence: 99%

Simultaneous Quantification of Formoterol Fumarate and Glycopyrrolate Using Reverse Phase High Performance Liquid Chromatography

Kalaiselvan¹,

Rajarathinam²,

Chandran³

2018

Asian J. Chem.

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A fully validated and rapid RP-HPLC method suitable for the quantification of formoterol fumarate and glycopyrrolate combination is reported. Chromatographic separation was achieved on a Sunsil C18 analytical column (250 mm × 4.6 mm, 5 µ particle size). The analytes were detected and quantified by photodiode array detector set at 289 nm. Calibration curves were constructed in the range of 4.8-14.4 µg/ mL (R 2 = 0.9997) with a limit of quantification of 0.279 µg/mL for formoterol fumarate and 9-27 µg/mL (R 2 = 0.9998) with a limit of quantification 0.239 µg/mL for glycopyrrolate. The method was validated aaccording to ICH guidelines. The developed and validated RP-HPLC method was sensitive, selective, robust, accurate and precise for the simultaneous estimation of formoterol fumarate and glycopyrrolate in quality control laboratories.

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“…Fewer studies were conducted for salbutamol-4 -O-sulfate, most probably hampered by the non-availability of a reference substance. While for urine samples an easy dilute-and-inject approach has been shown to be feasible [29,[32][33][34][35], for the more complex serum samples mostly solid-phase extraction (SPE) [36][37][38][39][40][41][42][43][44][45][46] or liquid-liquid extraction (LLE) [47,48] have been demonstrated to allow for sensitive quantitation. However, sample clean up using SPE and LLE has also been used in the analysis of urine samples [30,41,[43][44][45][46][48][49][50].…”

Section: Introductionmentioning

confidence: 99%

Quantitation of Formoterol, Salbutamol, and Salbutamol-4′-O-Sulfate in Human Urine and Serum via UHPLC-MS/MS

et al. 2023

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The adrenergic beta-2 agonists formoterol and salbutamol are used for the treatment of asthma and COPD but are also misused in sports competitions. Therefore, they are included in WADA regulations. Both drugs are mainly excreted in urine after administration via inhalation. A four-armed, double-blind cross-over clinical trial was conducted involving endurance-trained participants (12 females and 12 males). Inhalation dosages of 36 μg formoterol, 1200 μg salbutamol, a combination of both, or a placebo were administered before exercise. Serum and urine were collected after exercise and 3 and 24 h after administration. Here, we show the successful quantitation of formoterol, salbutamol, and its phase II metabolite salbutamol-4′-O-sulfate in all urine and serum samples using ultra-high performance liquid chromatography–tandem mass spectrometry. In the serum analysis, results of up to 14.2 pg/mL formoterol, 10.0 ng/mL salbutamol, and 21.4 ng/mL salbutamol-4′-O-sulfate (calculated as salbutamol equivalent) were found. In urine, maximum concentrations (after deglucuronidation) were 17.2 ng/mL formoterol, 948.5 ng/mL salbutamol, and 2738.5 ng/mL salbutamol-4′-O-sulfate. Sex-specific differences in serum concentrations as well as in urinary excretion were observed. The results pronounce the importance of the implementation and elucidation of phase II metabolites to quantitation methods in antidoping.

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Ultra-sensitive determination of Formoterol in human serum by high performance liquid chromatography and electrospray tandem mass spectrometry

Cited by 9 publications

References 13 publications

Exposure-Response and Clinical Outcome Modeling of Inhaled Budesonide/Formoterol Combination in Asthma Patients

Exposure-Response and Clinical Outcome Modeling of Inhaled Budesonide/Formoterol Combination in Asthma Patients

Simultaneous Quantification of Formoterol Fumarate and Glycopyrrolate Using Reverse Phase High Performance Liquid Chromatography

Quantitation of Formoterol, Salbutamol, and Salbutamol-4′-O-Sulfate in Human Urine and Serum via UHPLC-MS/MS

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