Abstract
ENANTIOMERIC SEPARATION AND QUANTITATIVE DETERMINATION OF RITONAVIR ENANTIOMER IN RITONAVIR DRUG SUBSTANCE BY CHIRAL LIQUID CHROMATOGRAPHY

M. Subbarao*, M. Ramakrishna, D. Mogilireddy, M. Yanadhirao and Y. Pavani

ABSTRACT

A stability indicating analytical method was developed for the determination of ritonavir enantiomer in ritonavir drug substance by chiral liquid chromatography. The chromatographic separation was achieved on chiralpak IC which is an immobilized (cellulose tris-(3,5 dichlorophenylcarbamate) phase coated on silica matrix. The separation achieved employing a mobile phase consists of n-hexane, ethanol and diethylamine as mobile phase. the flow rate was 1.0 ml/ minute and ultra violet detector at 240nm. The average retention time for Rotonavir and Enantiomer found to be 15.0 min and 18.0 min the proposed method was validated for selectivity, precision, linearity and accuracy.

Keywords: Ritonavir, Isocratic, HPLC, Chiral pak IC, n-Hexane, Ethanol and Diethylamine and validation


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