Abstract

DEVELOPMENT OF VALIDATED CHIRAL RP-HPLC-PDA METHOD FOR THE ESTIMATION OF CETIRIZINE ENANTIOMERS IN BULK AND DOSAGE FORMS

Buchi N. Nalluri*, M. Lakshmi Prasanna and Tharun Kumar B.

ABSTRACT

A simple and precise chiral reverse-phase high pressure liquid chromatographic method was developed to separate and estimate the enantiomeric forms of Cetirizine (CET) in bulk and dosage forms. Chiral analysis was performed on Phenomenex Lux Cellulose-4 column (250×4.6mm, 5μ) using 0.02% Trifluoro acetic acid: Acetonitrile (72:28 v/v) as mobile phase at 1mL/min flow rate. The eluents were monitored at 230nm using PDA detector with an injection volume of 20μL. The retention times for CET enantiomers L and D were 10 and 12 minutes respectively with good peaks resolution and showed good linearity in the concentration range of 10-50μg/mL (R2>0.999). The limit of detection and limit of quantification were found to be 0.002μg/mL, 0.0062μg/mL for L-CET and 0.010μg/mL, 0.032μg/mL for D-CET respectively. The developed method was validated as per International Conference on Harmonization guidelines and successfully applied for the enatioselective analysis of CET in bulk and dosage forms.

Keywords: Chiral separation, Cetirizine, Reverse phase HPLC, PDA detector.