Liquid chromatographic determination of alogliptin in bulk and in its pharmaceutical preparation

Abstract

In this work, a reversed-phase liquid chromatographic (RP-LC) method has been developed for the determination of alogliptin (ALG) based on isocratic elution using a mobile phase consisting of potassium dihydrogen phosphate buffer pH (4.6)-acetonitrile (20:80, v/v) at a flow rate of 1 mL min(-1) with UV detection at 215 nm. Chromatographic separation was achieved on a Symmetry(®) cyanide column (150 mm × 4.6 mm, 5 μm). Linearity, accuracy and precision were found to be acceptable over the concentration range of 5-160 μg mL(-1) for ALG in bulk. The optimized method was validated and proved to be specific, robust and accurate for the quality control of ALG in pharmaceutical preparations.

Keywords: alogliptin; isocratic elution; pharmaceutical preparation; reversed-phase liquid chromatography.

Figure 1

Chemical structure of alogliptin.

Figure 2

A typical LC chromatogram with ultraviolet detection of 25 μL injector of alogliptin in bulk sample solution (50 μg mL^-1).

Figure 3

A typical LC chromatogram with ultraviolet detection of 25 μL injector of Nesina^® sample solution (50 μg mL^-1).