Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR ANALYSIS OF POTENCIAL GENOTOXIC IMPURITIES OF CETIRIZINE DIHYDROCHLORIDE

Amit Gosar*, Deepesh Patil, Advait Avalaskar, Narendra Aarkashi, Ganesh Hunde, Srinivasan Kuduva and Sandip Deshmukh

Abstract

The present paper describes a simple gradient reverse phase HPLC Method for separation and determination of two potencial genotoxic impurities i.e. 1-chloro-2-(chloro(phenyl)methyl) benzene (2-CCPB) and (chloromethylene)dibenzene (CPB) from the other 18 impurities in Cetirizine Dihydrochloride. Good resolution between two impurities was achieved with Inertsil ODS-3 HP (150 x 4.6 x 3μm) column using gradient of 0.2% Orthophosphoric acid and Acetonitrile. The flow rate was 0.8ml/min and elution was monitored at 225nm. The factors involved in method development are discussed. This method is validated as per International Conference on Harmonization (ICH) guidelines.

Keywords: Cetirizine Dihydrochloride, Genotoxic, RP-HPLC, Gradient, Internation Conference on Harmonization (ICH) guidelines.