Publication: Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
Issued Date
2020-01-01
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ISSN
25868470
25868195
25868195
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2-s2.0-85085172310
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Mahidol University
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SCOPUS
Bibliographic Citation
Pharmaceutical Sciences Asia. Vol.47, No.2 (2020), 142-152
Suggested Citation
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. Pharmaceutical Sciences Asia. Vol.47, No.2 (2020), 142-152. doi:10.29090/psa.2020.02.019.0035 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/56300
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Title
Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of manidipine in human plasma
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Abstract
© 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.