GC
IndustriesPharma & Biopharma
ManufacturerAgilent Technologies
Importance of the topic
The accurate determination of ethanol and isopropanol content in hand sanitizers is critical to ensure product efficacy and public safety. Regulatory bodies such as the US Pharmacopeia recommend gas chromatography with flame ionization detection for reliable quantitation and identification of alcohols and potential contaminants.
Study objectives and overview
This application note demonstrates the use of the Agilent 8860 GC equipped with a DB-WAX Ultra Inert column and FID to analyze ethanol- and isopropanol-based sanitizers. The study follows USP <611> guidelines, employing an internal standard approach to evaluate chromatographic performance, quantitation accuracy, and system suitability.
Methodology and instrumention
Sample preparation involved calibrating five alcohols (methanol, ethanol, isopropanol, n-propanol, glycerin) at defined v/v ranges with acetonitrile as internal standard. Viscous gel samples were diluted for direct injection. Analytical conditions included:
- GC inlet split/splitless at 250 °C, split ratio 20:1
- Injection volume 0.2 µL using Agilent 7693A autosampler
- Helium carrier gas at 7 mL/min, constant flow
- Oven program: 50 °C hold 5 min, ramp 30 °C/min to 230 °C, hold 3 min
- FID detector at 250 °C with standard gas flows
- Column: Agilent J&W DB-WAX UI, 30 m × 0.53 mm ID × 1 µm film
Main results and discussion
System suitability met USP criteria: retention time RSD below 0.03%, peak tailing factors under 1.2, and resolution over 9 for key alcohol pairs. Calibration curves exhibited linearity with R2 above 0.997. Quantitation precision for volatile alcohols exceeded expectations, with relative standard deviations under 1%. Analysis of two sanitizer gels and one spray showed excellent agreement with labeled ethanol and isopropanol contents, no methanol detected, and reliable detection of glycerin and n-propanol.
Benefits and practical applications
This GC-FID method provides a fast, automated, and robust approach for routine quality control of hand sanitizers. Key advantages include high throughput for viscous samples, accurate quantitation of active ingredients and impurities, and compliance with pharmacopeial requirements.
Future trends and opportunities
Emerging developments may focus on hyphenated techniques coupling GC to mass spectrometry for enhanced specificity, miniaturized or portable GC systems for field testing, green sample preparation to reduce solvent use, and integration with laboratory informatics for end-to-end automation and real-time monitoring.
Conclusion
The combination of the Agilent 8860 GC-FID with an Ultra Inert DB-WAX column delivers reliable, precise, and pharmacopeia-compliant analysis of alcohols in hand sanitizer products, supporting quality control and regulatory requirements.
References
- USP <611> Alcohol Determination, US Pharmacopeia Monograph, 2020
- ASTM D3695-95(2013) Standard Test Method for Volatile Alcohols in Water by Direct Aqueous-Injection GC
- Agilent Technologies Application Note 5994-1923EN: Analysis of Ethanol and Isopropyl Alcohol in Alcohol-Based Hand Sanitizers
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