ABSTRACT:
Validated for sertraline 1R4R cis enantiomer of sertraline hydrochloride in bulk drug and tablet using UV detector at 215 nm. The developed method was able to separate sertraline 1R4R cis enantiomer of sertraline hydrochloride from its bulk drug and tablet within 25 min. The chromatographic separation was carried out by reverse phase chromatography using column of protein based chiral stationary phase (Chiral AGP 100 mm x 4.0 mm x 5 µm) with mobile phase comprising of ammonium phosphate buffer and isopropanol (80:20, 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 sertraline 1R4R cis enantiomer were found to be 0.016 µg/mL and 0.05 µg/mL respectively. The linearity of response of sertraline 1R4R cis enantiomer was in the range of 0.05 µg/mL to 0.30 µg/mL with r > 0.9995. The percentage recovery of the sertraline 1R4R cis enantiomer from sertraline hydrochloride bulk drug sample ranged between 97.85 to 100.29 and for sertraline hydrochloride tablet ranged between 96.15 to 100.15. The method was validated and found to suitable for determination of sertraline 1R4R cis enantiomer of sertraline hydrochloride in bulk drug and tablet.