Development of normal phase chiral liquid chromatographic method for estimation of escitalopram oxalate and determination of R-citalopram enantiomer from escitalopram oxalate in bulk drug and tablet

Dighe V. V., Pawaskar P., Adhy

Abstract

A simple, sensitive, precise and high-performance liquid chromatographic (HPLC) method has been developed and validated for escitalopram oxalate and R-enantiomer of escitalopram oxalate in bulk drug and tablet using uv detector at 240 nm. The developed method was able to separate R-enantiomer of escitalopram oxalate from its bulk drug within 25 min. The chromatographic separation was carried out by normal phase chromatography using column of cellulose based chiral stationary phase (Chiralcel-OD 250mm x 4.6mm x 10μm) with mobile phase comprising of n-heptane, isoropanol, diethylamine (94.5:5:0.5, v/v/v) at a flow rate of 1.0 ml/min at 25°C temperature. The limit of detection (LOD) and limit of quantitation (LOQ) of R-enantiomer of escitalopram oxalate were found to be 0.16 μg/ml and 0.50 μg/ml respectively. The linearity of response of R-citalopram oxalate was in the range of 0.05 μg/ml to 7.5 μg/ml with r > 0.9999. The percentage recovery of the escitalopram oxalate for bulk drug sample ranged between 98.20 to 98.97 and for tablet ranged between 97.07 to 99.61. The percentage recovery of the R-citalopram oxalate from escitalopram oxalate bulk drug sample ranged between 97.41 to 100.79 and for escitalopram oxalate tablet ranged between 98.82 to 99.61. The method was validated and found to suitable for estimation of escitalopram oxalate and determination of R-citalopram oxalate from escitalopram oxalate bulk drug and tablet.

Relevant Publications in Journal of Chemical and Pharmaceutical Research