Development and Validation of a HPLC Method for Estimation of Loratadine and its Application to a Pharmacokinetic Study

A simple, rapid, sensitive and accurate high-performance liquid chromatography method was developed and validated for the quantification of loratadine concentration in rabbit plasma using metoclopramide as an internal standard. Separation was performed on kromosil C18 column (250 × 4.6 mm 5 μm) using a mobile phase consisting of 0.1% perchloric acid : acetonitrile (55:45 v/v) at a flow rate of 1 ml/min. Validation of the method was performed in order to demonstrate its selectivity, linearity, precision, accuracy, ruggedness, recovery and matrix effect. The calibration curves of loratadine were linear over a concentration range of 5–1022 μg/ml. The with-in and between-day of coefficients of variation were <10%. The extraction recoveries of loratadine at the three levels of quality control samples were 99.961%, 99.767% and 99.938%. The method was rapid with a retention time of loratadine and the internal standard observed at 6.67 and 8.83 min respectively. The developed method was successfully applied for studying the pharmacokinetics of loratadine in rabbits.