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

Abstract

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
stability- indicating 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-1
. 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