Quality assessment of liquid pharmaceutical preparations by HSS-GC-FID (CROSBI ID 174321)
Prilog u časopisu | izvorni znanstveni rad | međunarodna recenzija
Podaci o odgovornosti
Mornar, Ana ; Sertić, Miranda ; Nigović, Biljana
engleski
Quality assessment of liquid pharmaceutical preparations by HSS-GC-FID
A new headspace gas chromatographic method with flame ionization detection (HSS-GC-FID) was developed and validated for the determination of methanol as the main volatile impurity present in ethanolic pharmaceutical preparations. The use of static headspace sampling minimized the interference of other volatile matrix components and provided satisfactory results in purity assessment of different complex samples. The developed procedure revealed to be a rapid, sensitive, reproducible and accurate. The detection and quantification limits of methanol were 0.0003 and 0.0011% (v/v), respectively, and were sufficiently low to enable the estimation of organic volatile impurity according to the ICH guideline as well as the examination of methanol limit specified in European Pharmacopoeia for liquid pharmaceutical preparations. The proposed method was successfully applied to the analysis of diverse alcoholic herbal extracts and tinctures as well as ethanolic dermatological lotions.
static headspace; gas chromatography; quality control; methanol limit; liquid pharmaceutical preparations
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Podaci o izdanju
68 (11)
2013.
1076-1080
objavljeno
1061-9348
10.1134/S1061934813120071