Simple and rapid LC-MS/MS method for determination of sitagliptin in human plasma and application to bioequivalence study

Loh, Gabriel Onn Kit; Wong, Emily Yii Ling; Tan, Yvonne Tze Fung; Lee, Yi Lin; Pang, Lai Hui; Chin, May Chien; Damenthi, Nair; Peh, Kok Khiang

doi:10.1016/j.jchromb.2020.122337

Cited by 14 publications

(6 citation statements)

References 17 publications

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“…Five replicates of 3250.32 ng/mL system suitability plasma samples, a solvent with a composition of water and methanol (1:1, v/v ) and LLOQ were used. System suitability was performed at the beginning, during and end of the run to evaluate the drift and carry over of the system for method validation runs [ 36 , 37 ].…”

Section: Methodsmentioning

confidence: 99%

Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study

Loh¹,

Wong²,

Tan³

et al. 2022

Molecules

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Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were m/z 359.15 > 279.10 and m/z 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible.

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Section: Methodsmentioning

confidence: 99%

Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study

Loh¹,

Wong²,

Tan³

et al. 2022

Molecules

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“…System suitability was assessed at the beginning, during and at the end of each analytical run, in accordance with the method reported by Briscoe et al 15 and Loh et al 16 At the beginning of each analytical run, seven injections consisting of five high system suitability plasma samples (3200.28 ng/mL), one solvent (a mixture of water and methanol (50: 50, v/v) and one LLOQ (80.01 ng/mL) were injected into the system to monitor system performance. During analytical run (approximately 40–50 injections), a pair of high system suitability plasma samples (3200.28 ng/mL) were injected to ensure there was no system drift during the run.…”

Section: Methodsmentioning

confidence: 99%

“…At the end of each analytical run, a pair of high system suitability plasma samples, one solvent and one LLOQ were injected into the system. The acceptance criteria for the assessment of system suitability parameter were set in accordance with Loh et al 16…”

Section: Methodsmentioning

confidence: 99%

Sample preparation and quantification of polar drug, allopurinol, in human plasma using LCMSMS

Wong

Loh

Goh

et al. 2022

Eur J Mass Spectrom (Chichester)

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A fast, selective and reproducible LC-MS/MS method with simple sample preparation was developed and validated for a polar compound, allopurinol in human plasma, using acyclovir as internal standard (IS). Chromatographic separation was achieved using Agilent Poroshell 120 EC-C18 (100 × 2.1 mmID, 2.7 µm) analytical column. The mobile phase was comprised of 0.1%v/v formic acid-methanol (95:05; v/v), at a flow rate of 0.45 mL/min. The effect of different protein precipitation agents used in sample preparation such as methanol, acetonitrile, a mixture of acetonitrile-methanol and a mixture of acetonitrile-acetone were evaluated to optimize the extraction efficiency of allopurinol and IS. The use of acetone-acetonitrile (50:50, v/v) as protein precipitating agent shortened the sample preparation time and improved the recovery of allopurinol to above 93%. The IS-normalised matrix factors at two concentration levels were 1.0, with CV of 5.1% and 4.2%. Allopurinol in plasma was stable at benchtop for 24 h, in autosampler tray for 48 h, in instrumentation room for 48 h, in freezer after 7 freeze-thaw cycles and in freezer for 140 days. Allopurinol stock standard solutions were stable for 140 days at room temperature and in the chiller. The short sample run time of the validated bioanalytical method allowed high throughput analysis of plasma samples in pharmacokinetic study of an allopurinol formulation. The robustness and reproducibility of the bioanalytical method was reaffirmed through incurred sample reanalysis (ISR).

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“…During the preliminary stage of the experiment, both the DPZ enantiomrs and IS were exhibited good responses in the MRM mode with the ESI interface, which was consistent with the previously reported literature. [41][42] For the aim of further optimize the MS/MS parameters to acquire reliable and accurate results,the double MRM transitions were employed for qualitative and quantitive analysis. The optimization of each transition was executed by directly injected each aqueous solution of rac-DPZ and diphenhydramine (IS) at 100 mg/L.…”

Section: Optimization Of Mass Spectrometry Conditionsmentioning

confidence: 99%

Enantiomeric Separation of Dioxopromethazine and its Stereoselective Pharmacokinetics in Rats by HPLC-MS/MS

Lun

Zhang

Zhao

et al. 2021

Journal of Pharmaceutical Sciences

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Simple and rapid LC-MS/MS method for determination of sitagliptin in human plasma and application to bioequivalence study

Cited by 14 publications

References 17 publications

Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study

Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study

Sample preparation and quantification of polar drug, allopurinol, in human plasma using LCMSMS

Enantiomeric Separation of Dioxopromethazine and its Stereoselective Pharmacokinetics in Rats by HPLC-MS/MS

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