Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma

© 2020 Mahidol University - Faculty of Pharmacy. A sensitive and selective liquid chromatography tandem mass spectrometric (LC-MS/MS) analytical method has been validated to quantify manidipine in human plasma using desipramine as an internal standard (IS). Liquid-liquid extraction (LLE) with a mixt...

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Main Authors: Wannisa Thanakosai, Thitirat Pamorn, Waraphorn Sisan, Piyapat Pongnarin, Pinpilai Jutasompakorn
Other Authors: Faculty of Medicine, Siriraj Hospital, Mahidol University
Format: Article
Published: 2020
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Online Access:https://repository.li.mahidol.ac.th/handle/123456789/56300
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spelling th-mahidol.563002020-06-02T12:38:54Z Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma Wannisa Thanakosai Thitirat Pamorn Waraphorn Sisan Piyapat Pongnarin Pinpilai Jutasompakorn Faculty of Medicine, Siriraj Hospital, Mahidol University Medicine Pharmacology, Toxicology and Pharmaceutics © 2020 Mahidol University - Faculty of Pharmacy. A sensitive and selective liquid chromatography tandem mass spectrometric (LC-MS/MS) analytical method has been validated to quantify manidipine in human plasma using desipramine as an internal standard (IS). Liquid-liquid extraction (LLE) with a mixture of methyl-t-butyl ether and hexane (4:1, v/v) was used for sample preparation. The separation of analytes and internal standard was performed on a C18 column (3 mm x 50. mm, particle size 2.5 μm) with gradient elution of (A) 0.05% formic acid and (B) acetonitrile. The mass spectrometry method was performed employing positive electrospray ionization (ESI) operating in multiple reaction monitoring (MRM) mode, monitoring the transitions of m/z 610.98 > 166.95 for manidipine and m/z 266.95 > 235.94 for the IS. The total analytical run time was 6 min. The calibration curve was linear over manidipine concentrations ranging from 0.1 ng/mL to 20 ng/mL in plasma with a correlation coefficient (r2) of 0.995 or better. The lower limit of quantification (LLOQ) and limit of detection (LOD) for manidipine were 0.1 ng/mL and 0.0125 ng/mL, respectively. Accuracy and precision were within the acceptance criteria of the United States (US) Food and Drug Administration (FDA) guidelines. The rapid and highly sensitive LC-MS/MS method has been developed and successfully applied to a bioequivalence study of manidipine in Thai healthy volunteers after oral administration. 2020-06-02T05:18:41Z 2020-06-02T05:18:41Z 2020-01-01 Article Pharmaceutical Sciences Asia. Vol.47, No.2 (2020), 142-152 10.29090/psa.2020.02.019.0035 25868470 25868195 2-s2.0-85085172310 https://repository.li.mahidol.ac.th/handle/123456789/56300 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85085172310&origin=inward
institution Mahidol University
building Mahidol University Library
continent Asia
country Thailand
Thailand
content_provider Mahidol University Library
collection Mahidol University Institutional Repository
topic Medicine
Pharmacology, Toxicology and Pharmaceutics
spellingShingle Medicine
Pharmacology, Toxicology and Pharmaceutics
Wannisa Thanakosai
Thitirat Pamorn
Waraphorn Sisan
Piyapat Pongnarin
Pinpilai Jutasompakorn
Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
description © 2020 Mahidol University - Faculty of Pharmacy. A sensitive and selective liquid chromatography tandem mass spectrometric (LC-MS/MS) analytical method has been validated to quantify manidipine in human plasma using desipramine as an internal standard (IS). Liquid-liquid extraction (LLE) with a mixture of methyl-t-butyl ether and hexane (4:1, v/v) was used for sample preparation. The separation of analytes and internal standard was performed on a C18 column (3 mm x 50. mm, particle size 2.5 μm) with gradient elution of (A) 0.05% formic acid and (B) acetonitrile. The mass spectrometry method was performed employing positive electrospray ionization (ESI) operating in multiple reaction monitoring (MRM) mode, monitoring the transitions of m/z 610.98 > 166.95 for manidipine and m/z 266.95 > 235.94 for the IS. The total analytical run time was 6 min. The calibration curve was linear over manidipine concentrations ranging from 0.1 ng/mL to 20 ng/mL in plasma with a correlation coefficient (r2) of 0.995 or better. The lower limit of quantification (LLOQ) and limit of detection (LOD) for manidipine were 0.1 ng/mL and 0.0125 ng/mL, respectively. Accuracy and precision were within the acceptance criteria of the United States (US) Food and Drug Administration (FDA) guidelines. The rapid and highly sensitive LC-MS/MS method has been developed and successfully applied to a bioequivalence study of manidipine in Thai healthy volunteers after oral administration.
author2 Faculty of Medicine, Siriraj Hospital, Mahidol University
author_facet Faculty of Medicine, Siriraj Hospital, Mahidol University
Wannisa Thanakosai
Thitirat Pamorn
Waraphorn Sisan
Piyapat Pongnarin
Pinpilai Jutasompakorn
format Article
author Wannisa Thanakosai
Thitirat Pamorn
Waraphorn Sisan
Piyapat Pongnarin
Pinpilai Jutasompakorn
author_sort Wannisa Thanakosai
title Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
title_short Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
title_full Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
title_fullStr Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
title_full_unstemmed Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
title_sort development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
publishDate 2020
url https://repository.li.mahidol.ac.th/handle/123456789/56300
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