Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF ANTIDIABETIC DRUGS ALOGLIPTIN BENZOATE AND PIOGLITAZONE HCL IN PHARMACEUTICAL FORMULATION

Khushabu R. Patil*, Dr. Tushar A. Deshmukh and Dr. Vijay R. Patil

ABSTRACT

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 Cosmosil C18 column (150 x 4.6 mm, 5μm) with a mixture of Acetonitrile: 10 mM potassium dihydrogen phosphate (pH 2.5 adjusted with ortho phosphoric acid) (30:70 v/v) as mobile phase, at a flow rate of 1.0 ml/min. UV detection was performed at 230 nm. The method was validated according to ICH guidelines. The retention times of alogliptin benzoate and pioglitazone HCl were 6.24 ± 1.26 and 2.33 ± 1.37 min, respectively. Calibration plots were linear over the concentration ranges 10-50 μg/ml μg/ml and 5-25 μg/ml for alogliptin benzoate and pioglitazone HCl respectively. The Limits of detection were 0. 38 μg/ml and 0. 09 μg/ml and the quantification limit were 1.17 μg/ml and 0.27 μg/ml for alogliptin benzoate and pioglitazone HCl respectively. The assay was found to be 99.98 ± 0.17and 100.14 ± 0.28.

Keywords: Pioglitazone HCl, Alogliptin Benzoate, RP-HPLC, Validation.