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Pharmacokinetics and Bioequivalence of Haloperidol Tablet by Liquid Chromatographic Mass Spectrometry with Electrospray Ionization

Yun Min-Hyuk    (College of Pharmacy, Chungnam National University   ); Kwon Jun-Tack    (College of Medicine, Soonchunhyang University   ); Kwon Kwang-il    (College of Pharmacy, Chungnam National University  );
  • 초록

    The purpose of this study is to investigate the bioequivalence of two haloperidol 5 mg tablets, Myung In haloperidol (Myung In Pharm. Co., Ltd., test drug) and $Peridol^{R}$ (Whanin Pharm. Co., Ltd., reference drug), and also to estimate the pharmacokinetic parameters of haloperidol in Korean volunteers. The bioavailability and pharmacokinetics of haloperidol tablets were examined on 24 healthy volunteers who received a single oral dose of each preparation in the fasting state in a randomized balanced 2 way crossover design. After an oral dosing, blood samples were collected for a period of 60 h. Plasma concentrations of haloperidol were determined using a liquid chromatographic electrospray mass spectrometric (LC-MS) method. The pharmacokinetic parameters were calculated with noncompartmental pharmacokinetic analysis. The geometric means of $AUC_{0-60h} and C_{max}$ between test and reference formulations were $17.21\pm8.26 ng\cdot/mL vs 17.31\pm13.24 ng\cdot/mL and 0.87\pm0.74 ng/mL vs 0.85\pm0.62 ng/mL$ . respectively. The $90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-60h} and C_{max} were log0.9677{\sim}log1.1201 and log0.8208{\sim}log1.1981$ , respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug. The geometric means of other pharmacokinetic parameters ( $AUC_{inf}. t_{1/2}, V_{d}/F, and CL/F$ ) between test drug and reference drug were $21.75\pm8.50 ng{\cdot}h/mL vs 21.77\pm15.63 ng{\cdot}h/mL, 29.87\pm8.25 h vs 29.60\pm7.56 h, 11.51\pm5.45 L vs 12.90\pm6.12 L and 0.26\pm0.09 L/h vs 0.31\pm0.17 L/h$ , respectively. These observations indicate that the two formulation for haloperidol was bioequivalent and, thus, may be clinically interchangeable.


  • 주제어

    Haloperidol .   LC-MS .   Pharmacokinetic .   Bioequivalence .   Bioavailability.  

  • 참고문헌 (11)

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    9. Walter, S., Bauer, S., Roots, I., and Brockmoller, J., Quantification of the antipsychotics flupentixol and haloperidol in human serum by high-performance liquid chromatography with ultraviolet detection. J. Chromatography B, 720, 211-237 (1998) 
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 저자의 다른 논문

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