Mechanistic Study for the Simultaneous Determination of Metformin and Teneligliptin in Human Plasma using Hydrophilic Interaction Liquid Chromatography–MS/MS

Shah, Priyanka A.; Shrivastav, Pranav S.; Vanol, Pravin G.; Sanyal, Mallika

doi:10.4155/bio-2018-0007

Cited by 9 publications

(6 citation statements)

References 35 publications

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“…Moreover, to elute polar compounds such as metformin, the HILIC analytical column offers improved sensitivity because the percentage of organic solvents in the mobile phase is high [ 17 ]. In previous metformin quantitative analysis studies [ 6 , 8 , 11 , 19 , 20 ], an isocratic method was generally used, but in this paper, a gradient method was used to shorten the time of peak elution. Therefore, the time was shortened by 1.5 min compared with the 3.5 min in the Mistri et al study, which was the longest time of previous studies.…”

Section: Discussionmentioning

confidence: 99%

“…Last, the total chromatographic run time in this study was 2 min. In general, the analysis time has been longer than 2 min in some published studies [ 8 , 9 , 10 ].…”

Section: Discussionmentioning

confidence: 99%

“…Various bioanalytical methods for the determination of metformin in human-derived materials have been developed, including gas chromatography (GC) with mass spectrometry [ 5 ] and liquid chromatography (LC) with UV detection [ 6 , 7 ] or mass spectrometry [ 8 , 9 , 10 ]. GC methods require a complex derivatization procedure before mass spectrometry to compensate chromatographic issues as low volatility [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

“…The reported LC methods with UV detection have shown higher lower limit of quantification (LLOQ) concentration levels [ 6 , 7 ]. Additionally, LC-tandem mass spectrometry suffers from several disadvantages, such as requiring long chromatographic times [ 8 , 9 , 10 ], a lack of sensitivity [ 9 , 10 , 11 ], and the use of complicated sample preparation procedures, including liquid-liquid extraction [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

“…Last, the total chromatographic run time in this study was 2 min. In general, the analysis time has been longer than 2 min in some published studies [ 8 , 9 , 10 ].…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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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“…Administration (2018) and was similar to our previous work (Shah, Shrivastav, Vanol, & Sanyal, 2018). The detailed procedures for bioanalytical method validation are summarized in the Supporting Information.…”

Section: Validation Proceduresmentioning

confidence: 92%

Simultaneous quantitation of metformin and dapagliflozin in human plasma by LC–MS/MS: Application to a pharmacokinetic study

Shah

Shrivastav

Shah

et al. 2018

Biomedical Chromatography

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A single LC–MS/MS assay has been developed and validated for the simultaneous determination of metformin and dapagliflozin in human plasma using ion‐pair solid‐phase extraction. Chromatographic separation of the analytes and their internal standards was carried out on a reversed‐phase ACE 5CN (150 × 4.6 mm, 5 μm) column using acetonitrile–15 mm ammonium acetate, pH 4.5 (70:30, v/v) as the mobile phase. To achieve higher sensitivity and selectivity for the analytes, mass spectrometric analysis was performed using a polarity switching approach. Ion transitions studied using multiple reaction monitoring mode were m/z 130.1 [M + H]+/60.1 for metformin and m/z 467.1 [M + CH3COO]−/329.1 for dapagliflozin in the positive and negative modes, respectively. The linear calibration range of the assay was established from 1.00 to 2000 ng/mL for metformin and from 0.10 to 200 ng/mL for dapagliflozin to achieve a better assessment of the pharmacokinetics of the drugs. The limit of detection and limit of quantitation for the analytes were 0.39 and 1.0 ng/mL for metformin and 0.03 and 0.1 ng/mL for dapagliflozin, respectively. There was no interference of plasma matrix obtained from different sources, including hemolyzed and lipemic plasma. The method was successfully applied to study the effect of food on the pharmacokinetics of metformin and dapagliflozin in healthy subjects.

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A HILIC-MS/MS assay for the quantification of metformin and sitagliptin in human plasma and urine: A tool for studying drug transporter perturbation

Scherf‐Clavel

Kinzig

Stoffel

et al. 2019

Journal of Pharmaceutical and Biomedical Analysis

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Mechanistic Study for the Simultaneous Determination of Metformin and Teneligliptin in Human Plasma using Hydrophilic Interaction Liquid Chromatography–MS/MS

Abstract: The method was applied to determine plasma concentration of MET and TEN in healthy subjects.

Cited by 9 publications

References 35 publications

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

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

Simultaneous quantitation of metformin and dapagliflozin in human plasma by LC–MS/MS: Application to a pharmacokinetic study

A HILIC-MS/MS assay for the quantification of metformin and sitagliptin in human plasma and urine: A tool for studying drug transporter perturbation

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