Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of lurbinectedin in human plasma and urine

L van Andel; H Rosing; R Lubomirov; P Avilés; S Fudio; M M Tibben; L Nan-Offeringa; J H M Schellens; J H Beijnen

doi:10.1016/j.jpba.2018.05.053

Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of lurbinectedin in human plasma and urine

L van Andel, H Rosing, R Lubomirov, P Avilés, S Fudio, M M Tibben, L Nan-Offeringa, J H M Schellens, J H Beijnen

Department of Pharmacy & Pharmacology, Antoni van Leeuwenhoek/The Netherlands Cancer Institute and MC Slotervaart, Amsterdam, The Netherlands.
Pharma Mar, S.A. Colmenar Viejo, Madrid, Spain.

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Lurbinectedin is a novel highly selective inhibitor of RNA polymerase II triggering caspase-dependent apoptosis of cancerous cells. This article describes the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay to quantify lurbinectedin in human plasma and urine. Plasma samples were pre-treated with 1 M aqueous ammonia after which they were brought onto supported liquid extraction (SLE) columns. Lurbinectedin was eluted from the columns using tert-butyl methyl ether (TBME). Urine was first diluted in plasma and lurbinectedin was extracted from this matrix by liquid-liquid extraction using TBME. Samples were measured by LC-MS/MS in the positive electron ion spray mode. The method was linear over 0.1-100 ng/mL and 1-1000 ng/mL in plasma and urine, respectively, with accuracies and precisions within ±15% (20% for LLOQ) and below 15% (20% for LLOQ), respectively. The method was developed to support a mass balance study in which patients received a dose of 5 mg lurbinectedin.

Original language	English
Pages (from-to)	160-165
Number of pages	6
Journal	Journal of Pharmaceutical and Biomedical Analysis
Volume	158
DOIs	https://doi.org/10.1016/j.jpba.2018.05.053
Publication status	Published - 5 Sept 2018

Keywords

Lurbinectedin
PM01183
HPLC–MS/MS
Plasma
Urine
Bioanalysis

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10.1016/j.jpba.2018.05.053

1-s2.0-S0731708518311762-mainFinal published version, 510 KBLicence: Taverne

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van Andel, L., Rosing, H., Lubomirov, R., Avilés, P., Fudio, S., Tibben, M. M., Nan-Offeringa, L., Schellens, J. H. M., & Beijnen, J. H. (2018). Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of lurbinectedin in human plasma and urine. Journal of Pharmaceutical and Biomedical Analysis, 158, 160-165. https://doi.org/10.1016/j.jpba.2018.05.053

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title = "Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of lurbinectedin in human plasma and urine",

abstract = "Lurbinectedin is a novel highly selective inhibitor of RNA polymerase II triggering caspase-dependent apoptosis of cancerous cells. This article describes the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay to quantify lurbinectedin in human plasma and urine. Plasma samples were pre-treated with 1 M aqueous ammonia after which they were brought onto supported liquid extraction (SLE) columns. Lurbinectedin was eluted from the columns using tert-butyl methyl ether (TBME). Urine was first diluted in plasma and lurbinectedin was extracted from this matrix by liquid-liquid extraction using TBME. Samples were measured by LC-MS/MS in the positive electron ion spray mode. The method was linear over 0.1-100 ng/mL and 1-1000 ng/mL in plasma and urine, respectively, with accuracies and precisions within ±15% (20% for LLOQ) and below 15% (20% for LLOQ), respectively. The method was developed to support a mass balance study in which patients received a dose of 5 mg lurbinectedin.",

keywords = "Lurbinectedin, PM01183, HPLC–MS/MS, Plasma, Urine, Bioanalysis",

author = "{van Andel}, L and H Rosing and R Lubomirov and P Avil{\'e}s and S Fudio and Tibben, {M M} and L Nan-Offeringa and Schellens, {J H M} and Beijnen, {J H}",

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van Andel, L, Rosing, H, Lubomirov, R, Avilés, P, Fudio, S, Tibben, MM, Nan-Offeringa, L, Schellens, JHM & Beijnen, JH 2018, 'Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of lurbinectedin in human plasma and urine', Journal of Pharmaceutical and Biomedical Analysis, vol. 158, pp. 160-165. https://doi.org/10.1016/j.jpba.2018.05.053

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AU - van Andel, L

AU - Rosing, H

AU - Lubomirov, R

AU - Avilés, P

AU - Fudio, S

AU - Tibben, M M

AU - Nan-Offeringa, L

AU - Schellens, J H M

AU - Beijnen, J H

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AB - Lurbinectedin is a novel highly selective inhibitor of RNA polymerase II triggering caspase-dependent apoptosis of cancerous cells. This article describes the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay to quantify lurbinectedin in human plasma and urine. Plasma samples were pre-treated with 1 M aqueous ammonia after which they were brought onto supported liquid extraction (SLE) columns. Lurbinectedin was eluted from the columns using tert-butyl methyl ether (TBME). Urine was first diluted in plasma and lurbinectedin was extracted from this matrix by liquid-liquid extraction using TBME. Samples were measured by LC-MS/MS in the positive electron ion spray mode. The method was linear over 0.1-100 ng/mL and 1-1000 ng/mL in plasma and urine, respectively, with accuracies and precisions within ±15% (20% for LLOQ) and below 15% (20% for LLOQ), respectively. The method was developed to support a mass balance study in which patients received a dose of 5 mg lurbinectedin.

KW - Lurbinectedin

KW - PM01183

KW - HPLC–MS/MS

KW - Plasma

KW - Urine

KW - Bioanalysis

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DO - 10.1016/j.jpba.2018.05.053

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JO - Journal of Pharmaceutical and Biomedical Analysis

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ER -

Development and validation of a liquid chromatography-tandem mass spectrometry assay for the quantification of lurbinectedin in human plasma and urine

Abstract

Keywords

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