Analytical Method Development and Validation of LEAVOCETRIZINE HCL in Bulk and Pharmaceutical Dosage Form by RP-HPLC

Abstract

A simple rapid sensitive, precise method has been developed for the estimation of Leavocetrizine HCl in Dosage form (Syrup 0.5mg/ml) using Inertsil C18 column (250×4.62mm, 5µ) used for the separation. The mobile phase consisting of Buffer: Acetonitrile (35:65) of pH 3.0 adjusted with Ortho-phosphoric acid. The conditions optimized were: flow rate (1 ml/minute), wavelength (230 nm) and run time was 5 min. This method was validated for System suitability, Specificity, Accuracy, Linearity, Range, and Robustness. Leavocetrizine HCl was having retention time 2.35 min. in standard and syrup. The proposed method is good for obtaining reliable results and found to be suitable for the routine analysis in Leavocetrizine Hcl in pharmaceutical formulations. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug and met all specifications as per ICH guidelines.