VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF TENELIGLIPTIN IN TABLET DOSAGE FORM

Mayur Mahire and Padmanabh Deshpande*

ABSTRACT

A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for determination of Teneligliptin tablet dosage form. The mobile phase selected was Toluene: Methanol: Triethylamine (8.5: 1.5: 0.5, v/v/v) with UV detection at 246 nm. The retention factor for Teneligliptin was found to be 0.42±0.06. The method was validated with respect to linearity, accuracy, precision and robustness. 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 400-2400 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 99.66 ± 1.11. The developed method can be used for checking the stability of Teneligliptin in bulk drug and pharmaceutical dosage form.

Keywords: Teneligliptin, HPTLC, Forced degradation, Tablet dosage form.