Simultaneous determination of buprenorphine, norbuprenorphine and naloxone in human plasma by LC-MS-MS

Ting Yi Chiang, Li Heng Pao, Cheng Huei Hsiong, Pei Wei Huang, Kai Wei Lin, Oliver Yoa Pu Hu

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

A novel sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS-MS) method simultaneously determined buprenorphine (BUP) and its active metabolite, norbuprenorphine (NBUP), and a coformulant, naloxone was developed, validated and applied successfully in humans. Buprenorphine-d 4 and norbuprenorphine-d 3 were used as the internal standard. The analysis was performed on a silica column, and the mobile phase was isocratic and composed of acetonitrile:2 mM ammonium formate in H2O (82:18, v/v). Mass spectrometry employed multiple reaction monitoring modes with transitions of m/z 468.1-55.2 for BUP, 414.2-101.2 for NBUP, 328.3-310.3 for naloxone, 472.1-59.2 for buprenorphine-d 4 and 417.2-101.2 for norbuprenorphine-d 3. Lower limit of quantification (LLOQ) of the analytical method was 0.05 ng mL-1 for BUP, 0.1 ng mL-1 for NBUP and 0.025 ng mL-1 for naloxone, respectively. The standard calibration curves of BUP, NBUP and naloxone were linear over the concentration range of 0.05-20 ng mL-1, 0.1-20 ng mL-1 and 0.025-20 ng mL-1, respectively. The precisions (RSD) and accuracies (RE) of LLOQ and other QC samples were in acceptable range, with RSD < 20% and RE ± 20% for LLOQ and RSD < 15% and RE within ±15% for QC samples. The method was accurate, precise and specific, and was applied to the pharmacokinetic study of buprenorphine in healthy volunteers.

Original languageEnglish
Pages (from-to)575-583
Number of pages9
JournalChromatographia
Volume74
Issue number7-8
DOIs
Publication statusPublished - Oct 1 2011
Externally publishedYes

Fingerprint

Plasma (human)
Buprenorphine
Naloxone
formic acid
Mass spectrometry
Tandem Mass Spectrometry
Pharmacokinetics
Liquid Chromatography
Silicon Dioxide
Liquid chromatography
Calibration
Metabolites
norbuprenorphine
Naloxone Drug Combination Buprenorphine
Mass Spectrometry
Healthy Volunteers
Monitoring

Keywords

  • Buprenorphine
  • LC-MS-MS
  • Naloxone
  • Norbuprenorphine
  • Pharmacokinetics

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Clinical Biochemistry
  • Organic Chemistry

Cite this

Chiang, T. Y., Pao, L. H., Hsiong, C. H., Huang, P. W., Lin, K. W., & Hu, O. Y. P. (2011). Simultaneous determination of buprenorphine, norbuprenorphine and naloxone in human plasma by LC-MS-MS. Chromatographia, 74(7-8), 575-583. https://doi.org/10.1007/s10337-011-2095-2

Simultaneous determination of buprenorphine, norbuprenorphine and naloxone in human plasma by LC-MS-MS. / Chiang, Ting Yi; Pao, Li Heng; Hsiong, Cheng Huei; Huang, Pei Wei; Lin, Kai Wei; Hu, Oliver Yoa Pu.

In: Chromatographia, Vol. 74, No. 7-8, 01.10.2011, p. 575-583.

Research output: Contribution to journalArticle

Chiang, Ting Yi ; Pao, Li Heng ; Hsiong, Cheng Huei ; Huang, Pei Wei ; Lin, Kai Wei ; Hu, Oliver Yoa Pu. / Simultaneous determination of buprenorphine, norbuprenorphine and naloxone in human plasma by LC-MS-MS. In: Chromatographia. 2011 ; Vol. 74, No. 7-8. pp. 575-583.
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abstract = "A novel sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS-MS) method simultaneously determined buprenorphine (BUP) and its active metabolite, norbuprenorphine (NBUP), and a coformulant, naloxone was developed, validated and applied successfully in humans. Buprenorphine-d 4 and norbuprenorphine-d 3 were used as the internal standard. The analysis was performed on a silica column, and the mobile phase was isocratic and composed of acetonitrile:2 mM ammonium formate in H2O (82:18, v/v). Mass spectrometry employed multiple reaction monitoring modes with transitions of m/z 468.1-55.2 for BUP, 414.2-101.2 for NBUP, 328.3-310.3 for naloxone, 472.1-59.2 for buprenorphine-d 4 and 417.2-101.2 for norbuprenorphine-d 3. Lower limit of quantification (LLOQ) of the analytical method was 0.05 ng mL-1 for BUP, 0.1 ng mL-1 for NBUP and 0.025 ng mL-1 for naloxone, respectively. The standard calibration curves of BUP, NBUP and naloxone were linear over the concentration range of 0.05-20 ng mL-1, 0.1-20 ng mL-1 and 0.025-20 ng mL-1, respectively. The precisions (RSD) and accuracies (RE) of LLOQ and other QC samples were in acceptable range, with RSD < 20{\%} and RE ± 20{\%} for LLOQ and RSD < 15{\%} and RE within ±15{\%} for QC samples. The method was accurate, precise and specific, and was applied to the pharmacokinetic study of buprenorphine in healthy volunteers.",
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