Stability-Indicating RP-HPLC Method Validation of Sertraline Hydrochloride and its Related Substances in Tablets

In the present study, a high-performance liquid chromatographic method was validated to evaluate purity of Sertraline Hydrochloride in tablet dosage form. Sertraline Hydrochloride and two related substances, trans isomer and 2,3-dichloro isomer of Sertraline hydrochloride, were well resolved using a ZORBAX RX C₈ column (250 mm × 4.6 mm, 5) with the mobile phase consisting of 50mM KH₂PO₄ containing 0.1% octane sulfonic acid sodium salt (pH: 2.5 with Dil. H₃PO₄, 0.2% Triethylamine) and methanol (43:57, v/v). Flow rate was kept at 1.0ml/min and the detection was carried out by UV at 215nm. Resolution between any pair of isomers was found to be more than 2. The Limit of detection and Limit of quantification for both trans isomer and 2,3-dichloro isomer of Sertraline Hydrochloride were 10ng/ml and 30ng/ml, respectively. The developed and optimized method was applicable for routine determination of Sertraline Hydrochloride and its trans isomer and 2,3-dichloro isomer in tablet dosage form with sufficient selectivity, precision and accuracy.