Abstract

STABILITY INDICATING CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ESCITALOPRAM OXALATE AND FLUPENTIXOL IN ITS PHARMACEUTICAL DOSAGE FORM BY HPLC

Damor Sheetalben Nareshkumar* and Darpini Patel

Abstract

Objective: An accurate, precise and simple stability indicating Chromatographic method for development and validation for the simultaneous estimation of Escitalopram Oxalate and Flupentixol in its pharmaceutical dosage form by HPLC and to perform stability study on developed method & validation method. Experiment Work: The best separation was achieved on a C18 Column (25 cm X 0.46 cm), C18 reversed phase column with Isocratic program, mobile phase APotassium Dihydrogen Phosphate Buffer, pH-5.5 &mobile phase BMethanol (35: 65), Flow rate 1.0 ml/min., Injection volume 20 μl, UV detection was performed by using wavelength at 302 nm. Result and Discussion: The method was linear over the concentration range of 20- 60 μg/ml (r2-0.9995), with limits of detection and quantification of 1.326 μg/ml & 4.019 μg/ml for Escitalopram Oxalate (r2-0.9995) and the method was linear over the concentration range of (1-3 μg/ml) (r2-0.9995) limits of detection and quantification of 0.070 μg/ml & 0.211 μg/ml for Flupentixol (r2-0.9995). Forced degradation study was carried out according to ICH guideline in all five conditions (Acid Degradation, Base Degradation, Oxidative Degradation, Thermal Degradation & Photo Degradation).

Keywords: Escitalopram Oxalate, Flupentixol, RP-HPLC, Degradation Studies.