Determination of Pioglitazone Hydrochloride in Human Plasma by High Performance Liquid Chromatography and Its Pharmacokinetics Application

Author

Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt

Abstract

Development of a simple, rapid and routine assay of Pioglitazone Hydrochloride (PHCl) for the
investigation of its pharmacokinetic parameters in human plasma and bioequivalence study of 45mg
PHCl tablets manufactured locally (Test) and originally (Reference). After extraction of PHCl from
plasma, it was chromatographed with mobile phase consisting of phosphate buffer: acetonitrile:
methanol (65:25:10) at flow rate of 2ml/min and detected at wavelength of 235nm. The
pharmacokinetic study was conducted in a 2 X 2 crossover design involving 24 volunteers. The criteria
used to assess bioequivalence of the two products were AUC(0-24), AUC(0-∞),Cmax, and tmax. The
described method for analysis showed that the recovery of PHCl from plasma was 99.84%, the limit of
detection was 0.05μg/ml and the regression analysis for the drug concentrations indicated excellent
linearity(r > 0.999). Statistical analysis (ANOVA) of the measured parameters showed that there was
no significant difference between the two products. The HPLC method presented is direct, simple,
reproducible, sensitive and linear for the determination of PHCl in human plasma & is adequate for its
clinical pharmacokinetic studies, besides, the Test was found to be bioequivalent to the Reference and
both products can be considered interchangeable in medical practice.

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