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