Young-Ho Park, Ji-Min Park, Eun Kyoung Chung, Su-Yeon Lee, Wang-Seob Shim and Kyung-Tae Lee Pages 559 - 565 ( 7 )
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.
Mazindol, bioequivalence study, liquid chromatography-tandem mass spectrometry, method validation, liquidliquid extraction, human plasma.
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