Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR RESIDUAL SOLVENT DICHLOROMETHANE IN VILAZODONE BY GAS CHROMATOGRAPHY TECHNIQUE

Syed Hussain S. K., Imam Pasha S.* and Mohammed Abdul Farhan

Abstract

This paper describes the analytical method for development and validation for residual solvent Dichloromethane in 3-(4-Chlorobutyl)- 1H-Indole-5-Carbonitrile by Gas chromatography technique. Proposed method is proven to be sensitive, simple and accurate for quantification of residual Dichloromethane in Vilazodone Hydrochloride. Retention time of Dichloromethane was found to be 6.3 minutes with septum purge flowrate of 3 mL/min by using Flame Ionization detector.The test method is linear for Dichloromethane over the range of LOQ to 150% of target concentration for the analyte response with an acceptable correlation coefficient values at 100% drug. The test method is accurate over the range of LOQ to 150% of target concentration for the estimation of residual solvent in 3-(chlorobutyl)-1H-indole-5-carbonitrile.The test method is rugged for day to day and analyst to analyst variability.

Keywords: Dichloromethane; Residual; Vilazofone Hydrochloride; GC method.