Abstract

Avalidated chiralLCmethod for the enantiomeric separation of sertraline hydrochloride in bulk drug samples and pharmaceutical dosage forms

Author(s): P.Radhakrishnanand, D.V.Subba Rao, K.V.Surendranath

A simple and new isocratic polar mode chiral HPLC method has been developed for the enantiomeric separation of sertraline hydrochloride in bulk drugs and dosage forms with an elution time of about 15 min. The separation was achieved on immobilized amylose based chiral stationary phase (Chiralpak-IA) using 0.1%diethylamine inmethanol asmobile phase. Themobile phase was delivered at 0.7mLmin-1 flowand the detectionwas monitored at 220 nmusing ultraviolet detection technique. The resolution (RS) between the sertraline and its (R, R)-enantiomer was found to bemore than 4.0.Themethod shows 0.005g as limit of detection (LOD) and 0.015g as limit of quantification (LOQ) for (R, R)-sertraline, for 10L injection volume. The validated method yield good results regarding precision, linearity and accuracy. The developed method shows excellent linearity (R2>0.999) over a range of LOQto 0.3%for (R, R)-sertraline. The percentage recovery of (R, R)-sertraline ranged from 98.3 to 101.8 in bulk drug samples and in pharmaceutical dosage forms. Robustness studies were also carried out on the develop method. The sertraline hydrochloride sample solution stability and mobile phase stability studies were carried out and the results were found to be satisfactory for a study period of 48h.