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Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study
A simple, rapid, and reliable UPLC-MS/MS method was developed and validated for the determination of tadalafil in human plasma. The plasma samples were deproteinized with acetonitrile. Chromatographic separation was performed on a Shiseido C18 (100 × 2.1 mm, 2.7 µm) column with isocratic elution usi...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Society for Clinical Pharmacology and Therapeutics
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033536/ https://www.ncbi.nlm.nih.gov/pubmed/32095455 http://dx.doi.org/10.12793/tcp.2017.25.1.21 |
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author | Kim, Kwang-Youl Nam, Moonsuk Kwon, Hyun-Jung Kim, Kwang-Hyeon Kang, Seung-Hyun Kim, Sang-Il Kim, Cheol-Woo Cho, Sang-Heon |
author_facet | Kim, Kwang-Youl Nam, Moonsuk Kwon, Hyun-Jung Kim, Kwang-Hyeon Kang, Seung-Hyun Kim, Sang-Il Kim, Cheol-Woo Cho, Sang-Heon |
author_sort | Kim, Kwang-Youl |
collection | PubMed |
description | A simple, rapid, and reliable UPLC-MS/MS method was developed and validated for the determination of tadalafil in human plasma. The plasma samples were deproteinized with acetonitrile. Chromatographic separation was performed on a Shiseido C18 (100 × 2.1 mm, 2.7 µm) column with isocratic elution using 2.0 mM ammonium acetate and acetonitrile (55:45, v/v) with 0.1% formic acid at a flow rate of 0.7 mL/min. The total run time was 1 min per sample. The quantitative analysis was performed using multiple reaction monitoring at transition of m/z 390.4 → 268.3 for tadalafil and m/z 475.3 → 283.3 for sildenafil as an internal standard. The method was fully validated over a concentration range of 5–1,000 ng/mL with a lower quantification limit of 5 ng/mL. Intra- and inter-day precision (relative standard deviation, %RSD) were within 8.4% and accuracy (relative error, %RE) was lower than -3.2%. The developed and validated method was successfully applied to a pharmacokinetic study of tadalafil (20 mg) in Korean healthy male subjects (n = 12). |
format | Online Article Text |
id | pubmed-7033536 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Korean Society for Clinical Pharmacology and Therapeutics |
record_format | MEDLINE/PubMed |
spelling | pubmed-70335362020-02-24 Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study Kim, Kwang-Youl Nam, Moonsuk Kwon, Hyun-Jung Kim, Kwang-Hyeon Kang, Seung-Hyun Kim, Sang-Il Kim, Cheol-Woo Cho, Sang-Heon Transl Clin Pharmacol Original Article A simple, rapid, and reliable UPLC-MS/MS method was developed and validated for the determination of tadalafil in human plasma. The plasma samples were deproteinized with acetonitrile. Chromatographic separation was performed on a Shiseido C18 (100 × 2.1 mm, 2.7 µm) column with isocratic elution using 2.0 mM ammonium acetate and acetonitrile (55:45, v/v) with 0.1% formic acid at a flow rate of 0.7 mL/min. The total run time was 1 min per sample. The quantitative analysis was performed using multiple reaction monitoring at transition of m/z 390.4 → 268.3 for tadalafil and m/z 475.3 → 283.3 for sildenafil as an internal standard. The method was fully validated over a concentration range of 5–1,000 ng/mL with a lower quantification limit of 5 ng/mL. Intra- and inter-day precision (relative standard deviation, %RSD) were within 8.4% and accuracy (relative error, %RE) was lower than -3.2%. The developed and validated method was successfully applied to a pharmacokinetic study of tadalafil (20 mg) in Korean healthy male subjects (n = 12). Korean Society for Clinical Pharmacology and Therapeutics 2017-03 2017-03-15 /pmc/articles/PMC7033536/ /pubmed/32095455 http://dx.doi.org/10.12793/tcp.2017.25.1.21 Text en Copyright © 2017 Translational and Clinical Pharmacology http://creativecommons.org/licenses/by-nc/3.0/ It is identical to the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/). |
spellingShingle | Original Article Kim, Kwang-Youl Nam, Moonsuk Kwon, Hyun-Jung Kim, Kwang-Hyeon Kang, Seung-Hyun Kim, Sang-Il Kim, Cheol-Woo Cho, Sang-Heon Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
title | Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
title_full | Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
title_fullStr | Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
title_full_unstemmed | Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
title_short | Validated UPLC-MS/MS method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
title_sort | validated uplc-ms/ms method for the determination of tadalafil in human plasma and its application to a pharmacokinetic study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033536/ https://www.ncbi.nlm.nih.gov/pubmed/32095455 http://dx.doi.org/10.12793/tcp.2017.25.1.21 |
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