A chemometric comparison of different models in fluorescence analysis of dabigatran etexilate and dabigatran

Wang, Tong; Liu, Qian; Long, Wanjun; Chen, An‐Qi; Yu, Ru‐Qin

doi:10.1016/j.saa.2020.118988

Cited by 7 publications

(5 citation statements)

References 46 publications

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“…The pure form of dabigatran and dabigatran 13 C 6 (IS) were provided by Clearsynth Limited, India, Hyderabad, India. Methanol and acetonitrile (ACN) (JT Baker), HCl, citric acid, ammonium formate (Merck), formic acid (AVRA), Water of Rankem; Strata-X 33 µm, polymeric sorbent of Pheno-menex make were procured and finally the human plasma sample was collected from the local blood bank.…”

Section: Methodsmentioning

confidence: 99%

“…Similarly, the quantification of total dabigatran in human plasma was performed by Abd Allah et al [12] using LC-MS/ MS technique. Using advanced technique, Wang et al [13] performed fluorescence chemometric comparison between dabigatran and a prodrug. The present work elucidates a novel rapid approach that possesses, cost-effectiveness and sensitivity for dabigatran, while considering its significance as a pharmaceutical agent.…”

Section: Introductionmentioning

confidence: 99%

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LC-MS/MS Bioanalytical Approach for the Quantitative Analysis of Dabigatran in Biological Fluids

Marella,

Bonthu,

Achanti

et al. 2023

ajc

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A novel bioanalytical methodology has been developed to establish a rapid and sensitive procedure for the detection of dabigatran in biological fluid, specifically human plasma. In this study, dabigatran 13C6 was utilized as an internal standard (IS). The solid phase extraction method was employed to extract dabigatran and internal standard (IS) from a plasma sample. The separated components are determined by utilizing a eluting mixture composed of 2 mM ammonium formate:methanol:acetonitrile (20:40:40 v/v/v). The procedure utilized a GL Sciences Ace C18 stationary phase with dimensions of 150 mm × 4.6 mm; 5 µm. The identification of dabigatran and IS was carried out using the MRM mode, which was chosen to minimize interference from the surrounding matrix. The measured m/z of the protonated precursor ion of dabigatran was 472.20, while the corresponding product ion has a m/z value of 289.10. The precursor ion with a m/z of 478.20 and the product ion with a m/z of 295.20 were generated by the internal standard (IS). Linearity was observed within the range of 1.016-304.025 ng/mL; r2 of 0.9956 and a sample size (n) of 5. The stability of the drug in plasma was evaluated through a series of tests. These tests included a 17 h period on a laboratory bench, 24 h in an injector, six cycles of freeze-thaw and a storage period of 7 days and 22 h at -20 ± 5 ºC. The results of these stability studies indicated that the drug remained stable in plasma. The method was subjected to validation and was determined to be qualified. The proposed analytical approach demonstrates potential for the routine analysis and pharmacokinetic study of dabigatran in biological fluids.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

LC-MS/MS Bioanalytical Approach for the Quantitative Analysis of Dabigatran in Biological Fluids

Marella,

Bonthu,

Achanti

et al. 2023

ajc

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“…Furthermore, it is known that MCR-ALS is capable of modeling systems that deviate slightly from bilinearity, as is the case with electrochemical data. 41 The only drawback of MCR-ALS lies in the rotational ambiguities that may arise. However, as mentioned earlier, these ambiguities can be overcome by applying appropriate constraints during the optimization process.…”

Section: Figures Of Merit and Analytical Performancementioning

confidence: 99%

Chemometrically assisted differential pulse voltammetry for simultaneous and interference-free quantification of gallic and caffeic acids

Montemerlo,

Azcarate,

Camiña

et al. 2024

Anal. Methods

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“…In reviewing the literature, numerous techniques were published for the quantification of DABE or DAB including liquid chromatography (Bernardi et al, 2013; Kumar et al, 2015; Nagadeep et al, 2019; Pani Kumar et al, 2015; Pantović et al, 2015; Schwertner & Stankus, 2016), UPLC–MS/MS (Baldelli et al, 2016; Cheah et al, 2014; Delavenne et al, 2012; Kozlov et al, 2019; Kuhn et al, 2015; Kuhn et al, 2018; Lagoutte‐Renosi et al, 2018; Nouman et al, 2015; Rodina et al, 2018; Saffian et al, 2015; Schmitz et al, 2014; Slavik et al, 2019), enzyme‐linked immunosorbent assay (ELISA; Hussain et al, 2015; Oiso et al, 2015), and spectrofluorimetry (Wang et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

“…Chemical structures of (a) dabigatran etexilate mesylate, (b) dabigatran, (c) dabigatran-d 3, and (d) conjugate dabigatran Delavenne et al, 2012;Kozlov et al, 2019;Kuhn et al, 2015;Kuhn et al, 2018;Lagoutte-Renosi et al, 2018;Nouman et al, 2015;Rodina et al, 2018;Saffian et al, 2015;Schmitz et al, 2014;Slavik et al, 2019), enzyme-linked immunosorbent assay (ELISA; Hussain et al, 2015;Oiso et al, 2015), and spectrofluorimetry (Wang et al, 2020).…”

mentioning

confidence: 99%

Development and validation of a ultraperformance liquid chromatography–tandem mass spectrometry method for quantifying free and total dabigatran in human plasma: An application for a bioequivalence study

Abd-Allah

Almrasy

Abdelhmaid³

et al. 2022

Biomedical Chromatography

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Dabigatran etexilate mesylate (DABE), a prodrug, quickly changes into dabigatran (DAB) after its oral administration. Accordingly, detecting DABE in plasma is practically unmanageable. An ultraperformance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) technique was developed and validated to compute free DAB in participants. For the first time, the central composite design, a type of response surface methodology, was applied for optimizing variables affecting the cleavage of glucuronide bond. In addition, the pharmacokinetic parameters of generic medication (okanadab) were determined, and the obtained outcomes were compared with those of the branded drug (pradaxa). The sample preparation was done using methanol as a protein precipitant and the separation was achieved using an ACQUITY UPLC BEH C18 column (2.1 × 50 mm, 1.7 μm). The elution was isocratically conducted using 10 mM ammonium formate:methanol (72:28, v/v) as a mobile phase and the flow rate was 0.25 mL/min. Multiple reaction monitoring and positive electrospray ionization were used. The determination was performed within 1 min, and the calibration growth curve was established over a range of 1.19–475 ng/mL using DAB‐d3 as a tagged internal standard. Bioequivalence research was validated following the US Food and Drug Administration (US FDA) guidelines for bioanalytical procedures and acceptable outcomes were achieved. The outcomes for okanadab and pradaxa did not differ significantly.

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A chemometric comparison of different models in fluorescence analysis of dabigatran etexilate and dabigatran

Cited by 7 publications

References 46 publications

LC-MS/MS Bioanalytical Approach for the Quantitative Analysis of Dabigatran in Biological Fluids

LC-MS/MS Bioanalytical Approach for the Quantitative Analysis of Dabigatran in Biological Fluids

Chemometrically assisted differential pulse voltammetry for simultaneous and interference-free quantification of gallic and caffeic acids

Development and validation of a ultraperformance liquid chromatography–tandem mass spectrometry method for quantifying free and total dabigatran in human plasma: An application for a bioequivalence study

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