Simultaneous determination of nalbuphine and its prodrug sebacoly dinalbuphine ester in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to pharmacokinetic study in humans

Pei Wei Huang, Hung Ta Liu, Cheng Huei Hsiong, Li Heng Pao, Chih Cherng Lu, Shung Tai Ho, Oliver Yoa Pu Hu

研究成果: 雜誌貢獻文章

5 引文 (Scopus)

摘要

A rapid, simple, sensitive and selective ultraperformance liquid chromatography-tandem spectrometry (UPLC-MS/MS) method for the determination of nalbuphine and its prodrug sebacoly dinalbuphine ester (SDE) was developed and validated in human plasma. The sample pretreatment involves basification and iterative liquid-liquid extraction with ethyl-ether-dichloromethane (7:3, v/v) solution, followed by LC separation and positive electrospray ionization (ESI) API-3000 mass spectrometry detection. The chromatography was on a Waters Acquity UPLC BEH HILIC column (2.1×100mm, 1.7μm). The mobile phase was composed of acetonitrile and water (83:17, v/v) that contained 0.2% formic acid and 4mm ammonium formate at a flow rate of 0.25mL/min. Ethylmorphine and naloxine were selected as the SDE and nalbuphine internal standard (IS), respectively. The calibration curve for both was linear over the range from 0.05 to 20ng/mL, with correlation coefficients ≥0.995. The lower limit of quantification was set at 0.05ng/mL. The intra- and inter-day precision values for nalbuphine and SDE were acceptable as per FDA guidelines. The method was applied successfully to determine nalbuphine concentration in human plasma samples obtained from four Taiwanese volunteers receiving intramuscularly administration of sebacoyl dinalbuphine ester. The method is sensitive, selective and directly applicable to human pharmacokinetic studies involving nalbuphine.
原文英語
頁(從 - 到)831-837
頁數7
期刊Biomedical Chromatography
27
發行號7
DOIs
出版狀態已發佈 - 七月 1 2013
對外發佈Yes

指紋

Nalbuphine
Plasma (human)
Pharmacokinetics
Liquid chromatography
Prodrugs
Tandem Mass Spectrometry
formic acid
Liquid Chromatography
Mass spectrometry
Esters
Ethylmorphine
Electrospray ionization
Liquid-Liquid Extraction
Water
Methylene Chloride
Liquids
Chromatography
Application programming interfaces (API)
Ether
Spectrometry

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Molecular Biology
  • Pharmacology
  • Drug Discovery
  • Clinical Biochemistry

引用此文

Simultaneous determination of nalbuphine and its prodrug sebacoly dinalbuphine ester in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to pharmacokinetic study in humans. / Huang, Pei Wei; Liu, Hung Ta; Hsiong, Cheng Huei; Pao, Li Heng; Lu, Chih Cherng; Ho, Shung Tai; Hu, Oliver Yoa Pu.

於: Biomedical Chromatography, 卷 27, 編號 7, 01.07.2013, p. 831-837.

研究成果: 雜誌貢獻文章

Huang, Pei Wei ; Liu, Hung Ta ; Hsiong, Cheng Huei ; Pao, Li Heng ; Lu, Chih Cherng ; Ho, Shung Tai ; Hu, Oliver Yoa Pu. / Simultaneous determination of nalbuphine and its prodrug sebacoly dinalbuphine ester in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to pharmacokinetic study in humans. 於: Biomedical Chromatography. 2013 ; 卷 27, 編號 7. 頁 831-837.
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abstract = "A rapid, simple, sensitive and selective ultraperformance liquid chromatography-tandem spectrometry (UPLC-MS/MS) method for the determination of nalbuphine and its prodrug sebacoly dinalbuphine ester (SDE) was developed and validated in human plasma. The sample pretreatment involves basification and iterative liquid-liquid extraction with ethyl-ether-dichloromethane (7:3, v/v) solution, followed by LC separation and positive electrospray ionization (ESI) API-3000 mass spectrometry detection. The chromatography was on a Waters Acquity UPLC BEH HILIC column (2.1×100mm, 1.7μm). The mobile phase was composed of acetonitrile and water (83:17, v/v) that contained 0.2{\%} formic acid and 4mm ammonium formate at a flow rate of 0.25mL/min. Ethylmorphine and naloxine were selected as the SDE and nalbuphine internal standard (IS), respectively. The calibration curve for both was linear over the range from 0.05 to 20ng/mL, with correlation coefficients ≥0.995. The lower limit of quantification was set at 0.05ng/mL. The intra- and inter-day precision values for nalbuphine and SDE were acceptable as per FDA guidelines. The method was applied successfully to determine nalbuphine concentration in human plasma samples obtained from four Taiwanese volunteers receiving intramuscularly administration of sebacoyl dinalbuphine ester. The method is sensitive, selective and directly applicable to human pharmacokinetic studies involving nalbuphine.",
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author = "Huang, {Pei Wei} and Liu, {Hung Ta} and Hsiong, {Cheng Huei} and Pao, {Li Heng} and Lu, {Chih Cherng} and Ho, {Shung Tai} and Hu, {Oliver Yoa Pu}",
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T1 - Simultaneous determination of nalbuphine and its prodrug sebacoly dinalbuphine ester in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to pharmacokinetic study in humans

AU - Huang, Pei Wei

AU - Liu, Hung Ta

AU - Hsiong, Cheng Huei

AU - Pao, Li Heng

AU - Lu, Chih Cherng

AU - Ho, Shung Tai

AU - Hu, Oliver Yoa Pu

PY - 2013/7/1

Y1 - 2013/7/1

N2 - A rapid, simple, sensitive and selective ultraperformance liquid chromatography-tandem spectrometry (UPLC-MS/MS) method for the determination of nalbuphine and its prodrug sebacoly dinalbuphine ester (SDE) was developed and validated in human plasma. The sample pretreatment involves basification and iterative liquid-liquid extraction with ethyl-ether-dichloromethane (7:3, v/v) solution, followed by LC separation and positive electrospray ionization (ESI) API-3000 mass spectrometry detection. The chromatography was on a Waters Acquity UPLC BEH HILIC column (2.1×100mm, 1.7μm). The mobile phase was composed of acetonitrile and water (83:17, v/v) that contained 0.2% formic acid and 4mm ammonium formate at a flow rate of 0.25mL/min. Ethylmorphine and naloxine were selected as the SDE and nalbuphine internal standard (IS), respectively. The calibration curve for both was linear over the range from 0.05 to 20ng/mL, with correlation coefficients ≥0.995. The lower limit of quantification was set at 0.05ng/mL. The intra- and inter-day precision values for nalbuphine and SDE were acceptable as per FDA guidelines. The method was applied successfully to determine nalbuphine concentration in human plasma samples obtained from four Taiwanese volunteers receiving intramuscularly administration of sebacoyl dinalbuphine ester. The method is sensitive, selective and directly applicable to human pharmacokinetic studies involving nalbuphine.

AB - A rapid, simple, sensitive and selective ultraperformance liquid chromatography-tandem spectrometry (UPLC-MS/MS) method for the determination of nalbuphine and its prodrug sebacoly dinalbuphine ester (SDE) was developed and validated in human plasma. The sample pretreatment involves basification and iterative liquid-liquid extraction with ethyl-ether-dichloromethane (7:3, v/v) solution, followed by LC separation and positive electrospray ionization (ESI) API-3000 mass spectrometry detection. The chromatography was on a Waters Acquity UPLC BEH HILIC column (2.1×100mm, 1.7μm). The mobile phase was composed of acetonitrile and water (83:17, v/v) that contained 0.2% formic acid and 4mm ammonium formate at a flow rate of 0.25mL/min. Ethylmorphine and naloxine were selected as the SDE and nalbuphine internal standard (IS), respectively. The calibration curve for both was linear over the range from 0.05 to 20ng/mL, with correlation coefficients ≥0.995. The lower limit of quantification was set at 0.05ng/mL. The intra- and inter-day precision values for nalbuphine and SDE were acceptable as per FDA guidelines. The method was applied successfully to determine nalbuphine concentration in human plasma samples obtained from four Taiwanese volunteers receiving intramuscularly administration of sebacoyl dinalbuphine ester. The method is sensitive, selective and directly applicable to human pharmacokinetic studies involving nalbuphine.

KW - Nalbuphine

KW - Sebacoyl dinalbuphine ester (SDE)

KW - UPLC-MS/MS

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