VALIDATED STABILITY-INDICATING HPTLC METHOD DEVELOPMENT FOR DETERMINATION OF VILDAGLIPTIN AS BULK DRUG AND IN TABLET DOSAGE FORM

Santosh R. Butle*, Padmanabh B. Deshpande

ABSTRACT

A new simple, accurate, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for estimation of Vildagliptin in tablet dosage form. The chromatographic separation was achieved by using Ethyl acetate: Methanol (8.5: 1.5, v/v) as mobile phase and UV detection at 217 nm. The retention factor for Vildagliptin was found to be 0.37 ± 0.003. The method was validated with respect to linearity, accuracy, precision 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 200-1000 ng band-1. The method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 100.61 ± 1.32. The developed method can be used for monitoring the stability of Vildagliptin in bulk drug and pharmaceutical dosage form.

Keywords: Vildagliptin, HPTLC, Forced degradation, Validation.