Development and validation of a reversed phase HPLC method for simultaneous determination of antidiabetic drugs alogliptin benzoate and pioglitazone HCl

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of alogliptin benzoate and pioglitazone HCl in bulk and tablet dosage form. Chromatographic analysis was performed on an Inertsil® ODS-3 column (250x4.6 mm, 5μm) with a mixture of methanol: phosphate buffer (pH 3) in the ratio 80:20 as mobile phase, at a flow rate of 1.0 mL min-1. UV detection was performed at 269 nm using DAD detector. The method was validated according to ICH guidelines. The retention times of alogliptin benzoate and pioglitazone HCl were 2.31±0.00 and 4.92±0.096 min, respectively. Calibration plots were linear over the concentration ranges 5-100 μg mL-1 for both drugs. The Limits of detection were170 and 215 ng mL-1and the quantification limit were 500 ngmL-1 and 650 ng mL-1 for alogliptin benzoate and pioglitazone HCl respectively. The accuracy of the proposed method was determined by recovery studies and was found to be 99.56% for alogliptinand101.38% for pioglitazone. The method was transferred to UPLC system using Syncronis®C18 column (50x 2.1 mm, 1.7 μm) and binary mixture was separated with good resolution within less than one minute.

Author(s): Mokhtar M. Mabrouk, Sherin F. Hammad, Fotouh R. Mansour and Mona M. Amer

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