Validated HS-GC-FID Method for Determination of Residual Ethanol in Solid Dosage Form

Validated HS-GC-FID Method for Determination of Residual Ethanol in Solid Dosage Form

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...

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Veröffentlicht in:Research journal of pharmacy and technology 2014-02, Vol.7 (2), p.184-187
Hauptverfasser: Alahmad, Shoeb, Almardini, Amer, Yahia, Mahzia
Format: Artikel
Sprache:eng
Schlagworte:
Ethanol
Gas chromatography
Headspace analysis
Residual Solvent
Validation
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Zusammenfassung: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.
ISSN:0974-3618
0974-360X