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. The HPLC analysis was performed on the Agilent 1200 system equipped with a Hypersil Gold Thermo Scientific C18 (250 cm × 4.6 mm) 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. The detection was performed at the wavelength (λ) of 277, and the retention time of alogliptin benzoate was around 4 min. The total run time was 6.0 min. The calibration plot gave linear relationship over the concentration range of 85–306 µg/ml. The LOD and LOQ were 0.03 and 0.09 μg, respectively. The accuracy of the proposed method was determined by recovery studies and was found to be 100.3%. The 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%. The results of robustness and solutions stability studies were within the acceptable limits as well. The 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.
Highlights
Since the first evidence about a known case of diabetes mellitus nearly 3000 years ago and despite the great deal of research that has been done recently, diabetes mellitus is still a wide spread serious disease that affect the life quality of millions of people worldwide
Incretin hormones are secreted in response to eating food from the gastrointestinal tract to the blood stream and can stimulate insulin secretion and help control glucose levels; that is, they prepare the body against increase in blood glucose. ese hormones include glucagon-like peptide-1 and glucose-dependent insulin tropic polypeptide [5, 6]
Several physical and chemical properties of alogliptin benzoate were obtained from the literature. e analytical method was developed to select preliminary reversed phase HPLC-UV
Summary
Since the first evidence about a known case of diabetes mellitus nearly 3000 years ago and despite the great deal of research that has been done recently, diabetes mellitus is still a wide spread serious disease that affect the life quality of millions of people worldwide. It is estimated that the number of patients with diabetes mellitus will rise to about 592 millions by the year 2035 [1, 2]. It was until the year 1936 that diabetes mellitus was distinguished to Type 1 and Type 2 [1]. Incretin hormones are secreted in response to eating food from the gastrointestinal tract to the blood stream and can stimulate insulin secretion and help control glucose levels; that is, they prepare the body against increase in blood glucose. Dipeptidyl peptidase-4 is an enzyme found in the human body that helps inactivate the incretin hormones, terminating their hypoglycemic effect [2]. Alogliptin a member of dipeptidyl peptidase-4 inhibitors is a recent
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