Improved liquid chromatography–tandem mass spectrometry method for the analysis of eptifibatide in human plasma

Zhou, Zhi‐Ling; Xin, Yu; Yang, Min; Mai, Liping; Lin, Qiaoli; Deng, Chunyu; Shan, Zhi‐Xin; Kuang, Su‐Juan; Zhu, Ping; Huang, Xiaozhong; Li, Xiaohong; Chen, Tie-Feng; Lin, Shu

doi:10.1016/j.jchromb.2010.06.012

Cited by 5 publications

(4 citation statements)

References 5 publications

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“…None of the reported methods utilized the intrinsic fluorescence of EPT for its direct assay in its pure form, pharmaceutical formulation or in human plasma. The aim of this study was to develop a simple and cheap spectrofluorimetric method to analyse the investigated drug in its pure form, pharmaceutical formulation and spiked human plasma, based on the affordability of fluorescence spectrophotometers in many laboratories compared with more expensive and sophisticated reported tandem mass spectrometry devices . The developed method was based on measuring the native fluorescence of EPT upon excitation with a suitable wavelength of maximum excitation intensity.…”

Section: Resultsmentioning

confidence: 99%

“…They created a semi‐aqueous formulation to improve drug stability during storage and transportation. Two liquid chromatography‐tandem mass spectrometric (LC‐MS/MS) methods were suggested for the analysis of EPT in plasma . EPT and its related peptide were determined in EPT injection by Yao and Chun‐Lai using a high pressure liquid chromatography ultraviolet (HPLC‐UV) method .…”

Section: Introductionmentioning

confidence: 99%

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Spectrofluorimetric determination of eptifibatide in human plasma and dosage form

et al. 2018

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A spectrofluorimetric method for the determination of eptifibatide is presented based on its native fluorescence. The type of solvent and the wavelength of maximum excitation and emission were carefully selected to optimize the experimental conditions. Under the specified experimental conditions, the linearities obtained between the emission intensity and the corresponding concentrations of eptifibatide were in the range 0.1–2.5 μg/ml for the calibration curve constructed for direct determination of eptifibatide in dosage form and 0.05–2.2 μg/ml for the calibration curve constructed in spiked human plasma with a good correlation coefficient (r > 0.99). The lower limit of quantification for the calibration curve constructed in human plasma was 0.05 μg/ml. Recovery results for eptifibatide in spiked plasma samples and in dosage form, represented as mean ± % RSD, were 95.17 ± 1.94 and 100.29 ± 1.33 respectively. The suggested procedures were validated according to the International Conference on Harmonization (ICH) guidelines for the direct determination of eptifibatide in its pure form and dosage form and United States Food and Drug Administration (US FDA) Guidance for Industry, Bioanalytical Method Validation for the assay of eptifibatide in human plasma.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Spectrofluorimetric determination of eptifibatide in human plasma and dosage form

et al. 2018

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“…18 The plasma concentrations of eptifibatide were determined using liquid chromatography-mass spectrometry (Shimadzu liquid chromatography model LC-20AB Prominence integrated system connected to an API 4000QTrap mass spectrometer; AB Sciex, Foster City, California). 18 The plasma concentrations of eptifibatide were determined using liquid chromatography-mass spectrometry (Shimadzu liquid chromatography model LC-20AB Prominence integrated system connected to an API 4000QTrap mass spectrometer; AB Sciex, Foster City, California).…”

Section: Analysis Of Eptifibatide By Liquid Chromatography-tandem Masmentioning

confidence: 99%

“…Eptifibatide was detected with a validated procedure previously reported in the literature. 18 The plasma concentrations of eptifibatide were determined using liquid chromatography-mass spectrometry (Shimadzu liquid chromatography model LC-20AB Prominence integrated system connected to an API 4000QTrap mass spectrometer; AB Sciex, Foster City, California). A Venusil ASB C18 column (4.4 mm × 150 mm, 5 μm) from Covance Medical Research and Development Co., Ltd. (Shanghai, China) was used.…”

Section: Analysis Of Eptifibatide By Liquid Chromatography-tandem Masmentioning

confidence: 99%

Clinical Evaluation of the Tolerability, Pharmacokinetics, and Inhibition of Platelet Aggregation of Eptifibatide in Healthy Chinese Subjects

Liu

Ding

Jiao

et al. 2019

Clinical Pharm in Drug Dev

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The present study aimed to evaluate the pharmacokinetic properties and antiplatelet aggregation activity of eptifibatide in healthy Chinese subjects. Eptifibatide (180 μg/kg) was administrated by 2 bolus injections 10 minutes apart, followed by a 2.0 μg/kg/min infusion for 24 hours. The eptifibatide pharmacokinetic and antiplatelet aggregation activities were evaluated using nonlinear mixed-effects modeling and noncompartmental analysis. Safety assessments included adverse events, hematology, and biochemistry tests. Twelve Chinese healthy subjects were enrolled and completed the study. Steady-state concentrations were achieved at 0.5 to 24 hours after dosing. The median time to maximum concentration was 13 minutes, and the mean terminal elimination half-life was 148.19 minutes. The effective inhibition of platelet aggregation (<20% platelet aggregation) occurred by 3 minutes after starting dosing to 4 hours after termination of the infusion. Eptifibatide concentrations were fitted with a 3-compartment model, and the typical value of clearance was 0.11 L/min,with no significant covariates found.Three mild adverse events were detected in the study.Eptifibatide displays high sensitivity and excellent tolerability in healthy Chinese subjects. The dosage of eptifibatide recommended on the label for whites can effectively inhibit platelet aggregation.

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Differential mobility spectrometry followed by tandem mass spectrometry with multiple ion monitoring for bioanalysis of eptifibatide in rat plasma

Ren

Meng

et al. 2018

Journal of Pharmaceutical and Biomedical Analysis

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Improved liquid chromatography–tandem mass spectrometry method for the analysis of eptifibatide in human plasma

Cited by 5 publications

References 5 publications

Spectrofluorimetric determination of eptifibatide in human plasma and dosage form

Spectrofluorimetric determination of eptifibatide in human plasma and dosage form

Clinical Evaluation of the Tolerability, Pharmacokinetics, and Inhibition of Platelet Aggregation of Eptifibatide in Healthy Chinese Subjects

Differential mobility spectrometry followed by tandem mass spectrometry with multiple ion monitoring for bioanalysis of eptifibatide in rat plasma

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