A VALIDATED NORMAL PHASE CHIRAL LC METHOD FOR THE ENANTIOMERIC SEPARATION OF SERTRALINE AND ITS Cis- (1R, 4R) ENANTIOMER ON AMYLOSE BASED STATIONARY PHASE

A simple and rapid chiral liquid chromatographic method was developed for the enantiomeric separation of Sertraline hydrochloride (cis-(1S, 4S)-4-(3, 4-dichlorophenyl)-N-methyl-1,2,3,4-tetrahydronaphthalen-1-amine hydrochloride) and its undesired cis-enantiomer (cis(1R, 4R)-4-(3, 4-dichlorophenyl)-N-methyl-1,2,3,4tetrahydronaphthalen-1-amine hydrochloride). Superior resolution between Sertraline and its cis-(1R, 4R) enantiomer was achieved on amylase based Chiralpak AD-H (250 x 4.6 mm, 5 μm particle size) column using hexane, isopropyl alcohol, ethanol and diethyl amine (850:100:50:0.1 v/v/v/v) as mobile phase at 25 °C temperature. Flow rate was kept as 1.0 ml/min and elution was monitored at 215 nm. The sample concentration was 0.3 mg/ml. The effects of the mobile phase composition, the flow rate and the temperature on the chromatographic separation were investigated. Developed method is capable to detect (LOD) and quantitate (LOQ) cis-(1R, 4R) enantiomer to the levels of 30 and 120 ng/ml respectively, for 10 μl injection volume. The percentage RSD of the peak area of six replicate injections of cis-(1R, 4R) enantiomer at LOQ concentration was 4.9. The percentage recoveries of cis-(1R, 4R) enantiomer from Sertraline were ranged from 93.8 to 103.9. The test solution and mobile phase was observed to be stable up to 24 h after the preparation. The developed method was validated with respect to limit of detection (LOD), limit of quantitation (LOQ), precision, linearity, accuracy, robustness and ruggedness.