DEVELOPMENT AND VALIDATION OF GAS CHROMATOGRAPHY METHOD FOR THE DETECTION OF RESIDUAL ETHANOL, ISOPROPYL ALCOHOL AND TOLUENE IN AMIODARONE HYDROCHLORIDE DRUG SUBSTANCE

摘要

A simple and reliable head space Gas Chromatographic method has been developed for the determination of residual ethanol, isopropyl alcohol and toluene in Amiodarone hydrochloride drug substance. The proposed method is based on flame ionization detection technique with DB 624 as stationary phase. Linearity of detector response was established up to 150 % of the limit level for ethanol, isopropyl alcohol and toluene and the quantitation limit was 80 ppm for ethanol, 40 ppm for isopropyl alcohol and 4 ppm for toluene respectively. Performance of the method was assessed by evaluating the recovery, repeatability, reproducibility, linearity and limits of detection and quantification. The proposed method has a potential for application to drug substances which may contains traces of residual solvents. Results prove that the validated method was suitable for determining the residual ethanol, isopropyl alcohol and toluene in Amiodarone hydrochloride drug substance.