STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DETERMINATION OF EBASTINE AS BULK DRUG AND IN TABLET DOSAGE FORM

Akshay S. Kale, Padmanabh B. Deshpande* and Sumit Saundale

ABSTRACT

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 Ebastine as bulk drug and in tablet dosage form. As stability testing is major step in the development of new drug as well as formulation, stress degradation studies were carried out according to ICH guidelines. Ebastine was found susceptible to all the analyzed stress conditions except photolysis. Chromatographic resolution of Ebastine and its degradation products was achieved by use of silica gel 60 F254 precoated aluminium plates as stationary phase and solvent mixture comprising of Ethyl acetate: Triethylamine (9.5: 0.5, v/v) as optimum mobile phase. Densitometric detection was carried out at 253 nm. The retention factor was found to be 0.59 ± 0.05. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The developed method was found to be linear in the concentration range of 100-600 ng band-1. The developed method has been effectively applied for the drug estimation in tablet dosage form.

Keywords: Ebastine, HPTLC, Forced degradation, Tablet dosage form, ICH.