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Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg)
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2009, v.22 no.1, pp.101-108
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(2009). Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg). Analytical Science and Technology, 22(1), 101-108.
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Abstract
The bioequivalence of two pioglitazone tablets, Actos<SUP>®</SUP> 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 C<SUB>max</SUB> ratio for Pioglitazone tablet and Actos<SUP>®</SUP> 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<SUP>®</SUP> tablet.
- keywords
- pioglitazone, bioequivalence, LC-MS/MS, analytical validation
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