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Development of Liquid Chromatography Tandem Mass Spectrometry Method for Determination of Mazindol in Human Plasma: Application to a Bioequivalence Study of Daewon Sanorex Tablet® (Mazindol 1 mg)

[ Vol. 13 , Issue. 6 ]

Author(s):

Young-Ho Park, Ji-Min Park, Eun Kyoung Chung, Su-Yeon Lee, Wang-Seob Shim and Kyung-Tae Lee*   Pages 559 - 565 ( 7 )

Abstract:


Introduction: A suitable liquid chromatography tandem mass spectrometry (LC–MS/MS) method to determine mazindol in human plasma is needed for bioequivalence and pharmacokinetic studies of celecoxib preparations. The present study describes a simple, rapid, reproducible, and reliable LC–MS/MS method to determine mazindol concentrations in human plasma.

Method: After one-step liquid–liquid extraction (LLE) using ethyl acetate : hexane = 8 : 2, mazindol and fluoxetine (internal standard, IS) were eluted on a Kinetex HILLIC column (50.0 × 2.1mm i.d. 2.6 µm) with an isocratic mobile phase, which consisted of 20 mM ammonium formate in water: acetonitrile (20:80, v/v) at a flow rate of 0.2 mL/min. The calibration curve was linear (correlation coefficient were > 0.99) over the concentration range (0.05-10 ng/mL).

Results: The intraday and interday precisions ranged 0.74 – 8.78% and 4.49 – 7.49%, respectively, and its accuracies ranged 92.00 – 108.48% and 97.73 – 105.20%, respectively. The stability of mazindol was evaluated by the addition of buffer to the plasma.

Conclusion: The devised method was successfully applied to bioequivalence study of two formulations of mazindol, Sanorex tablet® and Mazanor tablet® in 50 healthy Korean male volunteers following single oral administration.

Keywords:

Mazindol, bioequivalence study, liquid chromatography-tandem mass spectrometry, method validation, liquidliquid extraction, human plasma.

Affiliation:

Department of Life and Nanopharmaceutical Science, Department of Life and Nanopharmaceutical Science, Department of Pharmacy, College of Pharmacy, Kyung Hee Drug Analysis Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-Gu, Seoul, 130-701, Kyung Hee Drug Analysis Center, Kyung Hee University, Hoegi-Dong, Dongdaemun-Gu, Seoul, 130-701, College of Pharmacy, Kyung Hee University, Dongdaemun-Gu, Hoegi-Dong 130-701, Seoul

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