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...
Main Authors: | , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2013-08-01
|
Series: | Journal of Pharmaceutical Analysis |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2095177912001487 |
_version_ | 1818732800667287552 |
---|---|
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 |
first_indexed | 2024-12-17T23:39:20Z |
format | Article |
id | doaj.art-55e54a53705a4bd490309f75b439d95d |
institution | Directory Open Access Journal |
issn | 2095-1779 |
language | English |
last_indexed | 2024-12-17T23:39:20Z |
publishDate | 2013-08-01 |
publisher | Elsevier |
record_format | Article |
series | Journal of Pharmaceutical Analysis |
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 |
work_keys_str_mv | AT jinfengzhang ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT chunjiesha ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT yusun ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT yunyungai ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT jiyesun ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT jiangbinhan ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT xinshao ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT chunnasha ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT youxinli ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry AT wanhuiliu ultrahighperformanceliquidchromatographyforthedeterminationofexenatideinmonkeyplasmabytandemquadrupolemassspectrometry |