Abstract

DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD AND FORCE DEGRADATION STUDIES FOR ESTIMATION OF VORTIOXETINE HBR IN BULK DRUG AND DOSAGE FORM

Vivek G. Dhuri* and Dr. Purnima D. Hamrapurkar

Abstract

A simple, rapid high-performance liquid chromatographic method with PDA detection has been developed and validated according to the ICH guidelines for the estimation of Vortioxetine HBR in bulk drugs and d dosage form. Chromatographic separation was carried out in a INERTSIL ODS-3V C-18 column (250mm x 4.6mm x 5μ) with mobile phase composition of a mixture of Ammonium acetate(pH 4.5) and Acetonitrile (40:60) at a flow rate of 1ml/min and sample injection of 10 μL was injected. The eluent was monitored with a chrom nav software with PDA detector set at 228 nm with a total run time of 15 minutes. The method was linear over the concentration range of 2.5 to 7.5 μg/ml for Vortioxetine HBR with a correlation coefficient of 0.9960 Accuracy was found to be 99.58 to 101.17%. The developed and validated method was successfully applied to assay of Vortioxetine HBR In dosage form.

Keywords: Vortioxetine HBR, method development, RP-HPLC, PDA detector, stability indicating method, validation.