Method Development and Validation for Determination of Alcohol Contents in Hand Sanitizer Products by Headspace-Gas Chromatography- Flame Ionization Detector

Method Development for Determination of Alcohol Contents in Hand Sanitizer Products by HS-GC-FID

Abstract

        The Ministry of Public Health, Thailand, has issued a notification stating that alcohol-containing cosmetics for hand hygiene with a concentration ≥ 70% by volume of ethyl alcohol, isopropyl alcohol, or n-propyl alcohol, alone or combined, are allowed to be produced, imported, or sold, and methyl alcohol should not be used as an ingredient. The Bureau of Cosmetics and Hazardous Substances, Department of Medical Sciences, Thailand, developed a quantitative method for the determination of the four alcohols. The optimum extraction conditions for headspace were obtained at 70°C for 5 min. Gas Chromatograph conditions were performed using a DB-5 column with a temperature of 45°C and a flow rate of 0.5 mL/min. Method validation showed resolution > 2 of five alcohols, including tert-butyl alcohol as the internal standard. The linearity of the working range was from 0.50 to 8.00 mg/mL, with the Coefficient of Determination, R > 0.995. The accuracy was shown as % Recovery in the range of 95–110. The repeatability and intermediate precision were in an acceptable range (% RSD < 3). The Limit of detection and quantitation were 0.01 and 0.001% by volume, respectively. In summary, this method was appropriate to use in routine analysis. The advantages of this method were simple, convenient, fast, and capable of analyzing the content of all four alcohol components within 8 minutes.