Simultaneous Quantification of Antidiabetic Agents in Human Plasma by a UPLC–QToF-MS Method

Fachi, Mariana Millan; Cerqueira, Letícia Bonâncio; Leonart, Letícia Paula; Francisco, Thais Martins Guimarães de; Pontarolo, Roberto

doi:10.1371/journal.pone.0167107

Cited by 21 publications

(13 citation statements)

References 52 publications

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“…Generally, a LC-MS/MS method was applied to quantify small molecule drugs in bioanalytical samples because of sensitivity. However, due to the recent development of MS application technology, a LC-qTOF-MS also shows sufficient sensitivity to analyze bioanalytical samples, and many applications are applied in the references [ 28 29 30 31 ]. In addition, high resolution-full scan analysis using LC-qTOF-MS also can give us better picture of the metabolite profiles of the target compound.…”

Section: Resultsmentioning

confidence: 99%

Qualification and application of liquid chromatography-quadrupole time-of-flight mass spectrometric method for the determination of carisbamate in rat plasma and prediction of its human pharmacokinetics using physiologically based pharmacokinetic modeling

Lee

Lim

Park

et al. 2020

Transl Clin Pharmacol

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Carisbamate is an antiepileptic drug and it also has broad neuroprotective activity and anticonvulsant reaction. In this study, a liquid chromatography-quadrupole time-of-flight mass spectrometric (LC-qTOF-MS) method was developed and applied for the determination of carisbamate in rat plasma to support in vitro and in vivo studies. A quadratic regression (weighted 1/concentration 2), with an equation y = ax 2 + bx + c, was used to fit calibration curves over the concentration range from 9.05 to 6,600 ng/mL for carisbamate in rat plasma. Preclinical in vitro and in vivo studies of carisbamate have been studied through the developed bioanalytical method. Based on these study results, human pharmacokinetic (PK) profile has been predicted using physiologically based pharmacokinetic (PBPK) modeling. The PBPK model was optimized and validated by using the in vitro and in vivo data. The human PK of carisbamate after oral dosing of 750 mg was simulated by using this validated PBPK model. The human PK parameters and profiles predicted from the validated PBPK model were similar to the clinical data. This PBPK model developed from the preclinical data for carisbamate would be useful for predicting the PK of carisbamate in various clinical settings.

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Section: Resultsmentioning

confidence: 99%

Qualification and application of liquid chromatography-quadrupole time-of-flight mass spectrometric method for the determination of carisbamate in rat plasma and prediction of its human pharmacokinetics using physiologically based pharmacokinetic modeling

Lee

Lim

Park

et al. 2020

Transl Clin Pharmacol

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“…In some previous studies, the LLOQ concentration was greater than 5 ng/mL [ 6 , 9 , 10 , 11 , 16 ]. In the Fachi et al paper, when ultra-performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-QToF-MS) was used to develop an analysis method for quantifying various drugs including metformin in human plasma, the concentration of LLOQ was 250 ng/mL [ 16 ]. UPLC-QToF-MS is also HRMS, but in this study, the LLOQ concentration was 5 ng/mL and was determined using HRMS combined with a HILIC analytical column.…”

Section: Discussionmentioning

confidence: 99%

Bioanalytical Method Using Ultra-High-Performance Liquid Chromatography Coupled with High-Resolution Mass Spectrometry (UHPL-CHRMS) for the Detection of Metformin in Human Plasma

et al. 2020

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Metformin is the first-line medicine for the treatment of type 2 diabetes. Drug interactions between metformin and other drugs, food, or beverages cannot only cause changes in the pharmacokinetic profiles but also affect the efficacy of metformin. The purpose of this study was to develop a rapid and reliable bioanalytical method for the detection of plasma metformin concentration in humans. To remove interfering substances in plasma, acidified acetonitrile (acetonitrile containing 0.1% formic acid) was added to samples. Ultra-high-performance liquid chromatography (UHPLC) coupled with high resolution mass spectrometry (HRMS) was used to analyze metformin and its internal standard (metformin-d6). Analyte separation was performed on a BEH HILIC analytical column (100 × 2.1 mm, 1.7 μm) using a gradient elution of 0.1% formic acid (A) and acetonitrile with 0.1% formic acid (B). The total chromatographic run time was 2 min. The developed method was validated for its linearity, accuracy and precision, selectivity (signal of interfering substance; analyte, lower limit of quantification (LLOQ) ≤ 20%; IS, IS ≤ 5%), sensitivity (LLOQ, 5 ng/mL; S/N ratio ≥ 10), stability (low quality control (LQC, 15 ng/mL), 2.95–14.19%; high quality control (HQC, 1600 ng/mL), −9.49–15.10%), dilution integrity (diluted QC (4000 ng/mL); 10-folds diluted QC (400 ng/mL); 5-folds diluted QC (800 ng/mL); accuracy, 81.30–91.98%; precision, ≤4.47%), carry-over (signal of double blank; analyte, LLOQ ≤20%; IS, IS ≤5%), and matrix effect (LQC, 10.109%; HQC, 12.271%) under various conditions. The constructed calibration curves were shown linear in the concentration range of 5–2000 ng/mL, with within- and between-run precision values of <8.19% and accuracy in the range of 91.13–105.25%. The plasma metformin concentration of 16 healthy subjects was successfully measured by applying the validated bioanalytical method.

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“…Several methods have been reported in literature for the quantitation of metformin alone [ 8 , 9 , 10 , 11 , 12 ] or in combination with other drugs [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ] in biofluids. A number of other methods have also been reported in literature [ 22 ] for the quantitation of rosuvastatin alone [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ] or in combination with other drugs [ 31 , 32 ] in human plasma.…”

Section: Introductionmentioning

confidence: 99%

Hydrophilic Interaction Liquid Chromatography-Electrospray Ionization Mass Spectrometry for Therapeutic Drug Monitoring of Metformin and Rosuvastatin in Human Plasma

et al. 2018

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In this work a hydrophilic interaction liquid chromatography/positive ion electrospray mass spectrometric assay (HILIC/ESI-MS) has been developed and fully validated for the quantitation of metformin and rosuvastatin in human plasma. Sample preparation involved the use of 100 μL of human plasma, following protein precipitation and filtration. Metformin, rosuvastatin and 4-[2-(propylamino) ethyl] indoline 2 one hydrochloride (internal standard) were separated by using an X-Bridge-HILIC BEH analytical column (150.0 × 2.1 mm i.d., particle size 3.5 μm) with isocratic elution. A mobile phase consisting of 12% (v/v) 15 mM ammonium formate water solution in acetonitrile was used for the separation and pumped at a flow rate of 0.25 mL min−1. The linear range of the assay was 100 to 5000 ng mL−1 and 2 to 100 ng mL−1 for metformin and rosuvastatin, respectively. The current HILIC-ESI/MS method allows for the accurate and precise quantitation of metformin and rosuvastatin in human plasma with a simple sample preparation and a short a chromatographic run time (less than 15 min). Plasma samples from eight patients were further analysed proving the capability of the proposed method to support a wide range of clinical studies.

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Simultaneous Quantification of Antidiabetic Agents in Human Plasma by a UPLC–QToF-MS Method

Cited by 21 publications

References 52 publications

Qualification and application of liquid chromatography-quadrupole time-of-flight mass spectrometric method for the determination of carisbamate in rat plasma and prediction of its human pharmacokinetics using physiologically based pharmacokinetic modeling

Qualification and application of liquid chromatography-quadrupole time-of-flight mass spectrometric method for the determination of carisbamate in rat plasma and prediction of its human pharmacokinetics using physiologically based pharmacokinetic modeling

Bioanalytical Method Using Ultra-High-Performance Liquid Chromatography Coupled with High-Resolution Mass Spectrometry (UHPL-CHRMS) for the Detection of Metformin in Human Plasma

Hydrophilic Interaction Liquid Chromatography-Electrospray Ionization Mass Spectrometry for Therapeutic Drug Monitoring of Metformin and Rosuvastatin in Human Plasma

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