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KMID : 0385520090220010101
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Analytical Science & Technology
2009 Volume.22 No. 1 p.101 ~ p.108
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Bioequivalence of pioglitazone tablet to Actos® tablet (Pioglitazone 30 ㎎)
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Yeom Hye-Sun
Lee Tae-Ho
Youm Jeong-Rok
Song Jin-Ho
Han Sang-Beom
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Abstract
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The bioequivalence of two pioglitazone tablets, Actos® tablet (Takeda Chemical Industries, reference drug) and Pioglitazone tablet (Boryung Company, test drug) was evaluated according to the guidelines of Korea Food and Drug Administration. Twenty-eight healthy male Korean volunteers received each medicine (pioglitazone dose of 30 mg) in a 2×2 crossover study with one week washout interval. After drug administration, blood samples were collected at specific time intervals from 0-36 hours. The plasma concentrations of pioglitazone were determined by high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The total chromatographic run time was 5 min and calibration curves were linear over the concentration range of 5-2000 ng/mL for pioglitazone. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The primary calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two preparations. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for Pioglitazone tablet and Actos® tablet were log0.9422~log1.1040 and log0.9200~log1.1556, respectively. Based on the statistical considerations, we can conclude that the test drug, Pioglitazone tablet was bioequivalent to the reference drug, Actos® tablet.
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KEYWORD
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pioglitazone, bioequivalence, LC-MS/MS, analytical validation
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