Page 7 - Application Notebook - Hand Sanitizer Analysis

Application No. G333
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 Chromatogram and Calibration Curve of the  Chromatogram of Sample Solution and
Standard Solution Quantitative Result for Ethanol
The chromatogram and calibration curve of the The chromatogram of the sample solution is shown in
standard solution are shown in Fig. 3 and 4. The SST Fig. 5, and the quantitative results and repeatability
results of the standard solution are summarized in (n=3) are listed in Table 3.
Table 2.
The SST criteria include the following: Ethanol
• The resolution factor, R, between alcohol and the
internal standard be not less than 4. Acetonitrile
（IS）
• The tailing factor of the alcohol peak be not
greater than 2.0.
• Six replicate injections of the standard solution
show a relative standard deviation of not more
than 4.0 % in the ratio of the peak of alcohol to the
peak of the internal standard.
The results obtained with the standard solution
satisfied all three SST criteria. The requirement for
reproducibility (i.e. 4 %) was easily met with the RSD 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 min
of 0.4 %. Fig. 5 Chromatograms of Sample Solution

Ethanol Table 3 Ethanol Quantitative Values and Repeatability (n=3)
Area ratio Quantitative value (%)
Acetonitrile
（IS） Data 1 0.929279 78.997
Data 2 0.925411 78.668
Data 3 0.929298 78.998
Average 0.927996 78.888
%RSD 0.241 0.241
Note: The values shown are reference values and not intended to
be guaranteed values.

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 min
 Conclusion
Fig. 3 Chromatograms of Standard Solution
Alcohol concentration in sanitizer gel was determined
Area ratio using a capillary column in compliance with USP
<611> Method IIb.
0.9
The SST was conducted with a standard solution and
0.8
satisfied with the resolution of 10.3 (cf. > 4 as a
0.7
requirement) between ethanol and acetonitrile, the
0.6
tailing factor of 1.5 (cf. < 2 as a requirement) and the
0.5
repeatability of 0.4 % RSD (cf. 4 % limit).
0.4 The repeatability remained well even with a sample
0.3 solution, proving the robustness of the gas
0.2 chromatograph Nexis GC-2030.
0.1
0.0
0.0 0.1 0.2 0.3 0.4 Concentration
ratio Nexis is a trademark of Shimadzu Corporation in Japan and/or other
Fig. 4 Calibration Curve
countries.
Rtx is either a trademark or a registered trademark of Restek
Table 2 System Suitability of Standard Solution (n=6) Corporation in the United States and/or other countries.
Peak Area Area Symmetry Resolution
Compound
area ratio ratio %RSD (tailing) factor (USP)
Ethanol 627440 0.941074 0.405 1.467 ---
Acetonitrile (IS) 666723 --- 1.255 10.265 10.265
In Table 2, the items specified in the system suitability test are
indicated in red.
Note: The values shown are reference values, not guaranteed values. Note: The experiment in this article was performed based on the
current version of USP-NF as of April 24, 2020.
First Edition: Aug. 2020

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