HPLC METHOD FOR ANALYSIS OF CELIPROLOL ENANTIOMERS IN BIOLOGICAL FLUIDS AND PHARMACEUTICAL FORMULATION USING IMMOBILIZED POLYSACCHARIDE-BASED CHIRAL STATIONARY PHASE AND FLUORESCENCE DETECTION.

A sensitive and selective high performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of celiprolol enantiomers in human plasma, urine, and pharmaceutical formulation. Enantiomeric resolution was achieved on cellulose tris(3,5- dichlorophenyl carbamate) immobilized onto spherical porous silica chiral stationary phase known as Chiralpak IC with a fluorescence detection. The mobile phase consisted of n-hexane:ethanol:triethylamine (70:30:0.4%, v/v/v) has been used with a flow rate of 0.5 mL/min. S-(-)-acebutolol was used as the internal standard. The assay involved the use of acetonitrile for deproteinization of human plasma, and solid phase extraction (SPE) method for human urine samples prior to HPLC analysis. The method was validated in compliance with the international conference on harmonization (ICH) guidelines. The calibration curves were linear over the range of 5-250 ng/mL for each enantiomer. The detection limits of each enantiomer were 1.5 and 2.5 ng/mL in plasma and urine, respectively. The developed method applied for the determination of celiprolol enantiomers in urine, plasma and pharmaceutical formulations. Stress degradation studies as well as assay method indicated that, the method can be used as stability-indicating method and chiral quality control for celiprolol enantiomers by HPLC. [ABSTRACT FROM AUTHOR]