Design of Experimental approach for the quantification of Levocetirizine dihydrochloride dissolution in Tablets formulation using RL HPLC method

Abstract

The development of an analytical technique for the determination of drug by RP-HPLC. A simple, sensitive and reproducible method was established and validated for the concurrent estimation of Levocetirizine in its tablet preparation by reverse phase high performance liquid chromatography. The mobile phase containing phosphate buffer (pH 4.0 with ortho phosphoric acid) and acetonitrile in the proportion 65:35 v/v was selected because it was found to give a peak for Levocetirizine with minimum tailing. With the mentioned composition of mobile phase, sharp peak was achieved with reasonable short run time of 4.552 min. The criteria employed for assessing the suitability of above said solvent system were cost, time required for analysis, solvent noise, preparatory steps involved in the use of same solvent system for the extraction of the drug from formulation excipient matrix for the estimation of drug content. Hence this method can be applied for quantification of different formulations containing Levocetirizine simultaneously.