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Quality assessment of liquid pharmaceutical preparations by HSS-GC-FID (CROSBI ID 174321)

Prilog u časopisu | izvorni znanstveni rad | međunarodna recenzija

Mornar, Ana ; Sertić, Miranda ; Nigović, Biljana Quality assessment of liquid pharmaceutical preparations by HSS-GC-FID // Journal of analytical chemistry, 68 (2013), 11; 1076-1080. doi: 10.1134/S1061934813120071

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

Povezanost rada

Farmacija

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