Vol. 3, Issue 3 (2018)
Validation of the analytical method for the determination of residual solvents in albuterol sulphate through the chromatography of the gas analyzer
Author(s): Dr. Piyush M Maurya, Pathak Shriram Rameshrao
Abstract: In this paper validation of a GCHS method, for the determination of Residual solvents (Methanol, Isopropyl alcohol, Dichloromethane, Ethyl acetate, Tetrahydrofuran, Toluene) in Levalbuterol Sulphate using the BP-624, 30 m x 0.32mm ID, 1.8 μm columns as stationary phase, is described. The injection volume of samples taken is 1.2 ml with split less injection. The temperature maintained at the injector and detector was to be 200oC and 220oC respectively. Nitrogen gas with flow 2.0 ml/minute used as mobile phase and the detection was by FID. The flow of hydrogen and Air was maintained at 30ml/min and 300ml/min respectively. The method was validated as meets all the regulations of System suitability, Specificity, Method Precision, Linearity, LOD & LOQ, Precision of LOQ and Accuracy/Recovery under ICH specifications.