Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EBASTINE AND PHENYLEPHRINE IN BULK AND SOLID ORAL DOSAGE FORM BY HPLC

*Komal Parmar, Ankita Bhavsar, Bhagirath Patel

ABSTRACT

A simple, precise and accurate High Performance Liquid Chromatographic (HPLC) method has been developed and validated for simultaneous estimation of Ebastine and Phenylephrine in bulk and solid oral dosage form. The chromatographic separation was achieved on BDS hypersil C18 column. The wavelength selected was 272 nm, mobile phase used was Phosphate buffer (pH:3.5):Methanol (60:40) at 1.0 ml/min flow rate. The method was validated as per International Conference on Harmonisation (ICH) guidelines. In HPLC method linearity range was found to be 5-15 μg/ml for Ebastine and Phenylephrine. % Recovery were found to be 100.24% and 100.11 % for Ebastine and Phenylephrine respectively. The detection limit and quantitation limit were found to be 5 and 15.18 μg/ml for Ebastine and 1.83 and 5.56 μg/ml for Phenylephrine. % Assay was found to be 100.17 % and 99.27% for Ebastine and Phenylephrine respectively. The developed method can be used for routine quality control analysis of titled drugs in tablet formulation.

Keywords: HPLC, Ebastine, Phenylephrine, Method development, Method validation