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Development and Validation of Stereo Selective Method for the Separation of Razoxane Enantiomers in Hydrophilic Interaction Chromatography

Development and Validation of Stereo Selective Method for the Separation of Razoxane Enantiomers in Hydrophilic Interaction Chromatography

Ch Thirupathi, K Nagesh Kumar, G Srinivasu, Ch Lakshmi Narayana, Ch Parameswara Murthy

J Chromatogr Sci. 2018 Feb 1;56(2):147-153.

PMID: 29140426

Abstract:

A novel sensitive and high throughput chiral hydrophilic interaction chromatographic (HILIC) method was developed to separate razoxane enantiomers namely levrazoxane (R-isomer) and dexrazoxane (DEX) in pharmaceutical active ingredient samples. A systematic chiral chromatographic screening system was employed in using multiple HPLC chromatographic modes on various polysaccharide based chiral columns to obtain a potential separation between enantiomers. HPLC separation was achieved using a mobile phase of aqueous 10 mM ammonium bicarbonate and mixture of organic modifiers (70/30, v/v) in the ratio of (5/95, v/v) on an immobilized polysaccharide based chiral stationary phase namely CHIRALPAK IE-3. The chromatographic resolution between the enantiomers was found to be not <8 in the developed method. The values of the limit of detection and limit of quantification of DEX and levrazoxane were found to be 0.0037, 0.011 and 0.0043, 0.013 μgmL-1, respectively. The validated method yielded good results regarding precision, linearity, selectivity and found to be superior in sensitivity when compared to reported method for the accurate quantification of undesired enantiomer.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP21416671	Razoxane		21416-67-1	Price

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