Abstract

VALIDATED STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR DETERMINATION OF EBASTINE IN TABLET DOSAGE FORM

Akshay S. Kale and Padmanabh B. Deshpande*

Abstract

A new simple, accurate, precise and selective stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method for determination of Ebastine as bulk drug and in tablet dosage form has been developed and validated. The drug was exposed to hydrolytic, oxidative, thermal and photolytic stress conditions to check the stability nature of drug. Chromatographic resolution of Ebastine and its degradation products was accomplished by use of Jasco HPLC system equipped with HiQSil C18 column (150 x 4.6 mm i.d.) using Potassium dihydrogen o-phosphate buffer: Acetonitrile (30: 70, v/v) as mobile phase. Densitometric detection was carried out at 253 nm. The retention time was found to be 3.12 ± 0.02 min. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. Results were linear in the range of 5-30 μg mL-1. The developed method has been successfully applied for the estimation of drug in tablet dosage form.

Keywords: Ebastine, RP-HPLC, Forced degradation, Tablet dosage form, Validation.