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International Journal of
Pharmaceutical Science and Research
ARCHIVES
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
Authors
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.
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Pages:26-30
How to cite this article:
Dr. Piyush M Maurya, Pathak Shriram Rameshrao "Validation of the analytical method for the determination of residual solvents in albuterol sulphate through the chromatography of the gas analyzer". International Journal of Pharmaceutical Science and Research, Vol 3, Issue 3, 2018, Pages 26-30
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