Alogliptin

Alogliptin Benzoate is a novel hypoglycemic drug that belongs to dipeptidylpeptidase-4 inhibitor class which stimulates glucose dependent insulin release. The Present work describes development and validation of a new simple, accurate, precise and stability indicaing HPTLC method for the determination of alogliptin benzoate in tablet dosage form. The chromatographic separation was achieved by using Chloroform: Methanol 3:7 v/v as mobile phase and UV detection at 275 nm. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The drug was subjected to stress condition of acid hydrolysis, alkali hydrolysis, photolysis, thermal degradation. Results found to be linear in concentration range of 500-2500 ng/band. The developed method can be used for the quantification of bulk drug as well as tablet dosage form

A simple, specific, accurate, precise and sensitive RP- HPLC method has been developed for the rapid estimation of Alogliptin in bulk and its formulations. The chromatographic separation was carried on Phenomenex Gemini-NX-5 µm C18(2) 110A, LC Column 250 x 4.6 mm, using Acetonitrile:1-octasulphonoic acid (0.005mM) at pH-5 [60:40] (v/v) as mobile phase, at a flow rate of 1.0 ml/min.  The detection was carried out at 220 nm and drug eluted with a retention time of 3.48 min. Beer’s law was obeyed in the concentration range of 2-10?g/ml with correlation coefficient 0.9995. The method has been validated according to ICH guidelines for specificity, linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The method was found to be specific, accurate, and precise, robust, rugged and sensitive. The developed method was good linearity, novel, rapid for the estimation of Alogliptin in bulk and tablets dosage form. Thus it can be employed for the routine analysis.

A simple, rapid, accurate and precise high performance thin-layer chromatography (HPTLC) method was developed and validated for simultaneous estimation of alogliptin and metformin active pharmaceutical ingredients and fixed dose combination. Alogliptin and metformin densitograms were developed on silica gel 60 F254 HPTLC plates with chloroform: methanol: 0.5 % ammonium sulphate (4:4:2 %v/v) as mobile phase. Densitometric quantification was performed at 254 nm. For Alogliptin and Metformin Rf values were found as 0.66 and 0.44, respectively. The linearity curves of Alogliptin and Metformin were obtained in the concentration range of 100-500 ng/spot and 4000-20000 ng/spot by area with correlation co-efficient of 0.998 and 0.995 for Alogliptin and Metformin, respectively. Limit of detection was found to be 2 ng and 40 ng/spot for Alogliptin and Metformin, respectively; lowest possible quantity to be quantified by the proposed method was found to be 6 ng and 130 ng per spot for Alogliptin and Metformin, respectively. The method was validated for precision, accuracy, specificity and robustness. The developed method was validated and found to be selective, specific and suitable for application in pharmaceutical analysis of these drugs in bulk and fixed dose combination.

Type 2 Diabetes Mellitus is the most prevalent disease, affecting majority of the world’s population. There are plenty of antidiabetics available in the market helping in achieving glycaemia control. The use of DPP-4 inhibitor is one the effective approach for treating the disease. Alogliptin is the latest analogue to the DPP-4 inhibitor class, approved in 2013. It is a highly selective, oral inhibitor of DPP-4 enzyme. Along with Alogliptin, FDA approved the fixed dose combinations of Alogliptin with Metformin and Pioglitazone, in the same year. Clinical data demonstrate that administering Alogliptin alone or in combination, leads to reduction in mean HbA1c and Fasting Plasma Glucose (FPG) level. Mean reduction of HbA1c is about 0.5% to 0.6% with Alogliptin alone and on combination with Metformin and Pioglitazone, the mean HbA1c reduce approximately by 0.6% and 1.8% respectively. The drug also reduces the Fasting Plasma Glucose (FPG) level by 10mg/dl to 20mg/dl and in combination with Metformin and Pioglitazone, the FPG level reduce by 20mg/dl and 50mg/dl respectively. Alogliptin is a drug with suitable tolerance and high safety profile. The drug shows no incidence of hypoglycemia and is weight neutral. Hence, Alogliptin benzoate is the preferred choice of the drug to treat type 2 diabetes mellitus.