A stability indicating RP-UFLC method was developed and validated for the determination of alogliptin in tablet dosage form using Waters XSelectTM HSS PFP (150 X 4.6 mm, 2.5 µm particle size) analytical column with mobile phase consisting of acetonitrile-0.1%TEA in milli q water pH adjusted to 7.5, 60:40 v/v, at a flow rate of 1 ml / min with PDA detector at 276 nm. Linearity was observed over the concentration range 10.0-120.0 μg/ml and exhibited good correlation coefficient (r2 = 0.999) and excellent mean recovery (98.4-101.34%). The limit of detection and limit of quantification was found to be 0.0468 and 0.1418 respectively, which proved the adequate sensitivity of the method. Alogliptin was subjected to stress conditions including acidic, alkaline, oxidation and thermal degradation. The method was validated statistically as per ICH Q2 R1 guideline and the results were found to be satisfactory. The obtained results proved that the method can be employed for the routine analysis of alogliptin in bulk as well as in commercial formulation.
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