Identification of the primary impurity in ebastine and its souce analysis / 中国药学杂志

ABSTRACT

OBJECTIVE: To identify the structure of the primary unknown impurity of ebastine, thus offer technological support for reducing the impurity content and improving the quality of product. METHODS: The primary unknown impurity was separated and extracted from ebastine by preparative HPLC. The structure of the primary unknown impurity was analyzed by EI-MS, NMR, IR and UV and further confirmed with commercial reagent. RESULTS: The primary unknown impurity was elucidated as benzene, 1,1,2,2-tetra-phenyle thane, which is the by-product of ebasline synthesis. CONCLUSION: This study provides reference for the improvement of quality control and process optimization of ebastine.