Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry

A highly sensitive ultra-high-performance liquid chromatographicâtandem mass spectrometry (UPLC/MS/MS) method was developed for the quantification of the synthetic peptide drug of exenatide in monkey plasma. Sample preparation was carried out by solid-phase extraction (SPE), and bivalirudin was used...

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Main Authors: Jin-Feng Zhang, Chun-Jie Sha, Yu Sun, Yun-Yun Gai, Ji-Ye Sun, Jiang-Bin Han, Xin Shao, Chun-Na Sha, You-Xin Li, Wan-Hui Liu
Format: Article
Language:English
Published: Elsevier 2013-08-01
Series:Journal of Pharmaceutical Analysis
Online Access:http://www.sciencedirect.com/science/article/pii/S2095177912001487
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author Jin-Feng Zhang
Chun-Jie Sha
Yu Sun
Yun-Yun Gai
Ji-Ye Sun
Jiang-Bin Han
Xin Shao
Chun-Na Sha
You-Xin Li
Wan-Hui Liu
author_facet Jin-Feng Zhang
Chun-Jie Sha
Yu Sun
Yun-Yun Gai
Ji-Ye Sun
Jiang-Bin Han
Xin Shao
Chun-Na Sha
You-Xin Li
Wan-Hui Liu
author_sort Jin-Feng Zhang
collection DOAJ
description A highly sensitive ultra-high-performance liquid chromatographicâtandem mass spectrometry (UPLC/MS/MS) method was developed for the quantification of the synthetic peptide drug of exenatide in monkey plasma. Sample preparation was carried out by solid-phase extraction (SPE), and bivalirudin was used as the internal standard (IS). An excellent chromatographic separation was obtained on a reversed-phase C18 column with a gradient elution. Detection utilized a Qtrap 5500 system operated in the positive ion mode with multiple reaction monitoring (MRM). The proposed method was validated by assessing the specificity, linearity, intra- and inter-day precision and accuracy, recovery, and stability. The method resulted in a linear calibration range of 0.10â30ng/mL, extracting with only 50μL monkey plasma aliquots. The intra- and inter-day precisions (as relative standard deviation) were less than 7.5% and 9.6%, respectively. The method could be successfully utilized for the pharmacokinetic study of exenatide in monkeys following a single subcutaneous injection of Byetta. Keywords: Exenatide, UPLC/MS/MS, Quantitation, Pharmacokinetics, Plasma, Monkey
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spelling doaj.art-55e54a53705a4bd490309f75b439d95d2022-12-21T21:28:29ZengElsevierJournal of Pharmaceutical Analysis2095-17792013-08-0134235240Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometryJin-Feng Zhang0Chun-Jie Sha1Yu Sun2Yun-Yun Gai3Ji-Ye Sun4Jiang-Bin Han5Xin Shao6Chun-Na Sha7You-Xin Li8Wan-Hui Liu9School of Pharmacy, Yantai University, Yantai 264003, PR ChinaState Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR ChinaSchool of Pharmacy, Yantai University, Yantai 264003, PR ChinaState Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR ChinaState Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR ChinaState Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR ChinaState Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR ChinaRushan People's Hospital, Weihai 264200, PR ChinaState Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR ChinaSchool of Pharmacy, Yantai University, Yantai 264003, PR China; State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co. Ltd., Yantai 264003, PR China; Corresponding author at: School of Pharmacy, Yantai University, Yantai 264003, PR China. Tel.: +86 535 3808288.A highly sensitive ultra-high-performance liquid chromatographicâtandem mass spectrometry (UPLC/MS/MS) method was developed for the quantification of the synthetic peptide drug of exenatide in monkey plasma. Sample preparation was carried out by solid-phase extraction (SPE), and bivalirudin was used as the internal standard (IS). An excellent chromatographic separation was obtained on a reversed-phase C18 column with a gradient elution. Detection utilized a Qtrap 5500 system operated in the positive ion mode with multiple reaction monitoring (MRM). The proposed method was validated by assessing the specificity, linearity, intra- and inter-day precision and accuracy, recovery, and stability. The method resulted in a linear calibration range of 0.10â30ng/mL, extracting with only 50μL monkey plasma aliquots. The intra- and inter-day precisions (as relative standard deviation) were less than 7.5% and 9.6%, respectively. The method could be successfully utilized for the pharmacokinetic study of exenatide in monkeys following a single subcutaneous injection of Byetta. Keywords: Exenatide, UPLC/MS/MS, Quantitation, Pharmacokinetics, Plasma, Monkeyhttp://www.sciencedirect.com/science/article/pii/S2095177912001487
spellingShingle Jin-Feng Zhang
Chun-Jie Sha
Yu Sun
Yun-Yun Gai
Ji-Ye Sun
Jiang-Bin Han
Xin Shao
Chun-Na Sha
You-Xin Li
Wan-Hui Liu
Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
Journal of Pharmaceutical Analysis
title Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
title_full Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
title_fullStr Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
title_full_unstemmed Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
title_short Ultra-high-performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
title_sort ultra high performance liquid chromatography for the determination of exenatide in monkey plasma by tandem quadrupole mass spectrometry
url http://www.sciencedirect.com/science/article/pii/S2095177912001487
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