Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Ebastine and Phenylephrine Hydrochloride In Bulk And Pharmaceutical Dosage Form

摘要

ABSTRACT A simple UV-Visible spectrophotometric method is developed for the simultaneous determination of Ebastine and Phenylephrine hydrochloride in pharmaceutical dosage form using  the  first order derivative spectrophotometric method. The determination of both the drugs is based on the respective zero crossing point (ZCP) of their first order derivative spectra obtained in methanol. The first order derivative spectra were obtained using methanol as a solvent and the determinations were made at 241.0 nm (ZCP of Phenylephrine HCl) for Ebastine and 232.0 nm (ZCP of Ebastine) for Phenylephrine hydrochloride. The linearity was obtained in the concentration range of 4-24 μg/ml for both drugs and correlation coefficient (r2) were found to be 0.9994 and 0.9991 for Ebastine and Phenylephrine hydrochloride respectively. The percentage purity of drugs in combined tablet dosage form was found to be 100.02 % for Ebastine and 99.89 % for Phenylephrine hydrochloride. The % recoveries were found to be 99.88% for Ebastine and 99.24% for Phenylephrine hydrochloride.  The method was found to be simple, accurate and precise and was applicable for the simultaneous determination of Ebastine and Phenylephrine in tablet dosage form. Keywords: Ebastine (EBS), Phenylephrine hydrochloride (PHE), recovery, first order derivative spectrophotometric method, validation.