Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria
*Corresponding Author E-mail:
Online published on 27 March, 2014.
This paper describes HS-GC-FID method for the determination of ethanol residue in solid dosage forms manufactured by alcoholic granulation. The first step in this study is the validation. A description of the procedure and simple calculation of validation parameters was presented. Specificity of the method was determined. Linearity was observed in the range from 2500 ppm to 6000 ppm of ethanol, Correlation Factor was 0.994. The relative standard deviation for repeatability and intermediate precision was 12.13% and 6.6% respectively. The limit of detection was calculated to be 0.887 ppm of ethanol per sample. The total run is 8 minutes.
Validation, Residual Solvent, Ethanol, Gas chromatography, Headspace analysis
