Analytical Method Development and Validation of Alogliptin by RP-HPLC Method

A novel approach was used to develop and validate a rapid, specific, accurate and precise reverse phase high performance liquid chromatographic (HPLC) method for the estimation of Alogliptin phosphate mono-hydrate in pharmaceutical dosage forms. The chromatographic separation was achieved by Shiseido (250 x 4.6 mm, 5μm) column the using ratio of water and methanol as 75: 25(v/v). The flow rate was 1 mL/min and the detection wavelength was 225 nm. The limit of detection (LOD) for Alogliptin phosphate monohydrate was 0.23μg/mland the limit of quantification (LOQ) for Alogliptin phosphate monohydrate was 0.78 μg/ml. This method was validated with respect to linearity, accuracy, precision, specificity and robustness. The method was also found to be stability-indicating.