Naslov
Quality assessment of liquid pharmaceutical preparations by HSS-GC-FID

Autori
Mornar, Ana ; Sertić, Miranda ; Nigović, Biljana

Izvornik
Journal of analytical chemistry (1061-9348) 68 (2013), 11; 1076-1080

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
static headspace; gas chromatography; quality control; methanol limit; liquid pharmaceutical preparations

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA