A new, simple, precise, accurate and selective high performance thin-layer chromatographic (HPTLC) method has been developed and validated for the simultaneous estimation of Metformin hydrochloride (MET) and Alogliptin benzoate (ALG) in a tablet dosage form. Chromatographic separation was carried out on Merck HPTLC aluminium sheets of silica gel 60F254 using Acetonitrile: 1% ammonium acetate in Methanol (4.5:5.5 v/v) as mobile phase followed by densitometry analysis at 253 nm. The reliability of the method was assessed by evaluation of linearity (100-2500 ng/spot for Metformin hydrochloride as well as for Alogliptin benzoate). The accuracy of methods was assessed by recovery studies and was found to be within range of 98-102% for both Alogliptin benzoate and Metformin hydrochloride. The developed method was validated with respect to linearity, accuracy (recovery), and precision. The results were validated statistically as per ICH Q2 R1 guidelines and were found to be satisfactory. Due to non-availability of product, the simulation was done by using Glycomet® tablets (Metformin hydrochloride 250mg) and API of Alogliptin benzoate. The proposed method was successfully applied for the determination of Alogliptin benzoate and Metformin hydrochloride in the mixture.
