Development and validation of an HPLC method for determination of antidiabetic drug alogliptin benzoate in bulk and tablets

Abstract

Alogliptin benzoate, a member of dipeptidyl peptidase-4 inhibitors, is a recent drug developed by Takeda Pharmaceutical Company for the treatment of Type 2 diabetes; it potentiates the effect of incretin hormones through the inhibition of their degradation. Alogliptin can be used alone or in combination therapy. A new sensitive and rapid HPLC method was developed for the determination of alogliptin benzoate in bulk and pharmaceutical dosage forms; it was validated according to ICH and FDA guidelines. -e HPLC analysis was performed on the Agilent 1200 system equipped with a Hypersil Gold -ermo Scientific C18 (250 cm × 4.6mm) 5 μm column, with a mixture of acetonitrile and ammonium carbonate buffer in the ratio of 55 : 45 v/v as the mobile phase, at the flow rate of 1.0 mL/min. -e detection was performed at the wavelength (λ) of 277, and the retention time of alogliptin benzoate was around 4 min. -e total run time was 6.0 min. -e calibration plot gave linear relationship over the concentration range of 85–306 μg/ml. -e LOD and LOQ were 0.03 and 0.09 μg, respectively. -e accuracy of the proposed method was determined by recovery studies and was found to be 100.3%. -e repeatability testing for both standard and sample solutions showed that the method is precise within the acceptable limits. RSD% of the determination of precision was <2%. -e results of robustness and solutions stability studies were within the acceptable limits as well. -e proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria. In addition, the main features of the developed method are low run time and retention time around 4 min.