Development and Validation of Analytical Method by Reverse Phase HPLC for the Estimation of Escitalopram oxalate in Bulk and Dosage form

Abstract

Escitalopram Oxalate (EO) a well-known selective serotonin reuptake inhibitor (SSRI) shows an antidepressant activity. EO function is through raising serotonin levels in the brain, which is a chemical messenger. It regulates depressions of mental and physical symptoms, anxiety and obsessive-compulsive disorders. In this validation method, the HPLC was carried out on Waters -515 HPLC system with an Atlantis Hilic Silica, 5m, C-18 column (4.6250mm) Milford, USA. The identification of sample was done at 238nm, and the duration of retention was found roughly 4.7 minutes for EO. The total run time for the sample analysis was 6 minutes. A concentration ranging from 100-600µg/ml was prepared and the calibration plot revealed a linear relationship. The LOD and LOQ was found to be 111.27g and 337.19g respectively. The proposed method found to have 97 - 105.67% accuracy. The method precision was found within acceptable limits, according to conventional solution repeatability testing. The robustness results were also within acceptable limits. The proposed approach demonstrated outstanding linearity, accuracy, precision, robustness, and LOD and LOQ values that met the requirements. In addition, this new validated method has short run time and a retention time of 4.7 minutes. The present study designed and evaluated a speedy, simple, accurate, precise, and linear HPLC analytical method for EO stability indication. It can be used for quality control examination on a regular basis. The analytical method parameters and mobile phase solvents were found to give high resolution for Escitalopram Oxalate.