Determination of Content and Related Substances of Loratadine by HPLC

OBJECTIVE To establish an HPLC method for the determination of the content and related substances of loratadine. METHODS Agilent TC-C₁₈ column was used, the mobile phase consisted of acetonitrile-2% acetic acid solution, gradient elution. The flow rate was 1.0 mL·min^?1. The detection wavelength was 276 nm. RESUTLS Loratadine and its impurities could be separated with a good resolution. Loratadine, deslorata, N-methyldesloratadine, tricyclic ketone, impurity F and I were linear in the range of 3.2-106.7, 0.97-58.3, 0.59-35.5, 0.58-34.5, 0.59-35.4, 0.82-49.3 μg·mL^?1(r=0.999 4-0.999 9). CONCLUSION With good accuracy, sensitivity and reliability, the method can be applied to quality research and quality control of loratadine and its preparations.