Development and validation of a portable gas chromatograph method for quantitative determination of oxygen and toxic gas impurities in medical oxygen using planar microchromatographic columns and detectors
분석과학 / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2024, v.37 no.5, pp.261-270
Ekaterina V. Galeeva
(Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor / Yaroslavl State Medical University)
Roman R. Galeev
(Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor/Kazan Federal University / Yaroslavl State Medical University)
Prachi Sharma
(Vellore Institute of Technology (VIT) / Samara National Research University)
Alexander l. Khokhlov
(Yaroslavl State Medical University)
Dmitry V. Somov
(Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor)
Dmitry A. Semanov
(Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor / Kazan Federal University)
Ilshat R. Aryslanov
(Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor)
Natalia А. Lezhnina
(Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor / Yaroslavl State Medical University)
Vladimir Platonov
(Samara National Research University)
Nishant Tripathi
(Samara National Research University)
Ekaterina,
V.
G.
,
Roman,
R.
G.
,
Prachi,
S.
,
Alexander,
l.
K.
,
Dmitry,
V.
S.
,
Dmitry,
A.
S.
,
Ilshat,
R.
A.
,
Natalia,
А.
L.
,
Vladimir,
P.
,
&
Nishant,
T.
(2024). . 분석과학, 37(5), 261-270.
Abstract
: This study examines portable Gas Chromatography (GC) for the quantitative analysis of oxygen and impurities, focusing on the development and validation of a method to determine oxygen, carbon monoxide, carbon dioxide, methane, and nitrogen in medical compressed oxygen gas. The goal is to ensure the quality of medicalgrade oxygen. The method's validation assessed its metrological characteristics, demonstrating specificity through clear chromatographic separation of the target gases and the absence of these peaks in the carrier gas chromatogram.
It exhibited linearity within the designated concentration ranges, while precision met permissible standards, with the relative standard deviation for intermediate precision being less than 4 % for carbon monoxide (0.00025 − 0.00099 %), less than 3 % for methane (0.0005 − 0.00246 %) and carbon dioxide (0.0050 − 0.0150 %), less than 2 % for nitrogen (0.1 − 0.7 %), and less than 0.01% for oxygen (99.27 − 99.98 %). Overall, the validation results confirm the suitability of this analytical method for the quantitative determination of the aforementioned gases in medical compressed oxygen using portable GC with microchromatographic columns and detectors.
- keywords
-
oxygen,
medical gases,
gas chromatography,
planar microchromatographic columns,
quality control