Stability Indicating High Performance Thin Layer Chromatographic Determination of Alogliptin Benzoate as Bulk Drug and in Tablet Dosage Form

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 selective stabilityindicating high performance thin layer chromatographic (HPTLC) method for determination of Alogliptin Benzoate in tablet dosage form. The chromatographic separation was achieved by using Benzene: Ethyl acetate: Triethylamine (7.5: 2: 0.5, v/v/v) as mobile phase and UV detection at 222 nm. The retention factor for Alogliptin Benzoate was found to be 0.62 ± 0.10. 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 hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in the concentration range of 250-1500 ng band. The method has been successfully applied for the estimation of drug in tablet dosage form. The % assay (Mean ± S.D.) was found to be 99.56 ± 1.15. The developed method can be used for the quantification of drug in the dosage form, bulk drug as well as for routine analysis in quality control laboratories.