DEVELOPMENT OF RP-HPLC METHOD FOR THE ANALYSIS OF LORATADINE AND ITS APPLICATION IN THE EVALUATION OF MARKETED PREPARATION

A simple, selective, rapid and precise reversed-phase high-performance liquid chromatographic method for analysis of Loratadine in bulk and tablet dosage form has been developed and validated. Chromatography was performed on a Waters C18, 5µm particle size, 25cmx4.6mm i.d. with ACN : Methanol = 85 : 15 v/v as mobile phase at a flow rate of 1.0 mL min−1. UV detection was performed at 212 nm. Total run time was 10 min. Loratadine were eluted with retention time of 5.776 minutes. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with USP and ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 0-28μgmL−1 for Loratadine. Limit of detection were 0.06mg mL−1 and limit of quantification were 0.18mg mL−1 for Loratadine. The high recovery and low coefficients of variation confirm the suitability of the method for analysis of the drug in tablet dosage form. The validated method was successfully used for quantitative analysis of Loratin in Loratadine tablets.

Keywords: Analytical Method Development, Estimation, Loratadine, Linearity, RP-HPLC.