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Development and validation of an LC-MS/MS method for the determination of pelubiprofen and its active metabolite, trans-alcohol, in human plasma and its application to pharmacokinetic study.

Authors
  • Ryu, Ju-Hee1
  • Park, Ji-Sun2
  • Jo, Min-Ho3
  • Kim, Joo-Il4
  • Shim, Wang-Seob2
  • Kim, Bo-Hyung5
  • Yim, Sung-Vin5
  • Hong, Jongki6
  • Lee, Kyung-Tae7
  • 1 Department of Pharmaceutical Biochemistry, Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea; Department of Life and Nanopharmaceutical Science, and Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. , (North Korea)
  • 2 Kyung Hee Drug Analysis Center, College of Pharmacy, Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. , (North Korea)
  • 3 Department of Pharmaceutical Biochemistry, Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. , (North Korea)
  • 4 Department of Pharmaceutical Biochemistry, Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea; Daewon Pharm Co., Ltd, 389 Chenhodaero, Kwangjin-ku, Seoul 467-24, Republic of Korea. , (North Korea)
  • 5 Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. , (North Korea)
  • 6 Department of Life and Nanopharmaceutical Science, and Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. , (North Korea)
  • 7 Department of Pharmaceutical Biochemistry, Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea; Department of Life and Nanopharmaceutical Science, and Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea; Kyung Hee Drug Analysis Center, College of Pharmacy, Medical Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. Electronic address: [email protected] , (North Korea)
Type
Published Article
Journal
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
Publication Date
Mar 01, 2015
Volume
983-984
Pages
62–67
Identifiers
DOI: 10.1016/j.jchromb.2014.12.037
PMID: 25618252
Source
Medline
Keywords
License
Unknown

Abstract

A suitable liquid chromatography tandem mass spectrometry (LC-MS/MS) method is required to determine pelubiprofen and its active metabolite, trans-alcohol (M-D), in human plasma for pharmacokinetic studies of pelubiprofen preparations. After one-step liquid-liquid extraction (LLE) using methyl tert-butyl ether (MTBE), pelubiprofen, M-D, and tolbutamide (the internal standard, IS) were eluted from a Capcellpak C18 ACR column using a gradient mobile phase consisting of 0.1% formic acid in water and acetonitrile at a flow rate 0.35mL/min. The achieved lower limits of quantitation (LLOQ) of pelubiprofen and M-D were both 15ng/mL (S/N>10) and the standard calibration curves for pelubiprofen and M-D were linear (correlation coefficients >0.99) over the studied concentration range (15-2000ng/mL). Intra- and inter-day precisions were within 7.62% for all analytes and the deviation of assay accuracies was within ±13.23%. The developed method was successfully applied to a pharmacokinetic study of pelubiprofen in healthy Korean male volunteers.

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