Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2012 Vol: 4 Issue: 9

Stability Indicating HPLC Method for the Enantiomeric Separation of Fesoterodine Fumarate in Drug Product and Drug Substance Using Chiral Stationary Phase

Abstract

A chiral liquid chromatographic method was developed for the enantiomeric purity of Fesoterodine Fumarate in drug substance as well as in drug product. The chromatographic separation was achieved on Chiralpak IC-3, column using a mobile phase system consisting of n-hexane, isopropyl alcohol and diethyl amine in the ratio of 950:50:1 (v/v/v). The mobile phase was pumped through column at the flow rate of 1 mL min-1. Addition of diethyl amine in the mobile phase enhanced chromatographic efficiency and resolution between the enantiomers. The resolution between the enantiomers was found to be more than three. The developed method was subsequently validated and proved to be accurate, specific and precise. The experimentally established limit of detection and quantification for (S)-enantiomer of Fesoterodine were found to be 0.509 μg mL-1 and 1.316 μg mL-1 respectively for 20 μl injection volumes. The percentage recoveries of (S)-enantiomer was ranged between 95 to 105 % in drug product as well as in drug substance. The proposed method was found to be suitable and accurate for the quantitative determination of chiral purity of Fesoterodine Fumarate in drugs substance as well as in drug product.