Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF ANTIDIABETIC DRUGS ALOGLIPTIN BENZOATE AND METFORMIN 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 metformin 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 Methanol: 10 mM potassium dihydrogen phosphate pH 2.5 in the ratio 30:70 as mobile phase, at a flow rate of 1.0 ml/min. UV detection was performed at 224 nm. The method was validated according to ICH guidelines. The retention times of alogliptin benzoate and metformin HCl were 5.19 ± 0.98 and 1.70 ± 0min, respectively. Calibration plots were linear over the concentration ranges 4.25-21.25 μg/ml and 125-625 μg/ml for alogliptin benzoate and metformin HCl respectively. The Limits of detection were 0.08 μg/ml and 0.03 μg/ml and the quantification limit were 0.26 μg/ml and 0.11 μg/ml for alogliptin benzoate and pioglitazone HCl respectively. The assay was found to be 100.26 ± 0.09 and 100.23 ± 0.04.

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