摘要
Oleic acid is a common pharmaceutical excipient that has been widely used in various dosage forms. Gas chromatography （GC） has often been used as the quantitation method for fatty acids normally requiring a derivatization step. The aim of this study was to develop a simple, robust, and derivatization-free GC method that is suitable for routine analysis of all the major components in oleic acid USP-NF （United States Pharmacopeia-National Formulary） material. A gas chromatography-flame ionization detection （GC-FID） method was developed for direct quantitative analysis of oleic acid and related fatty acids in oleic acid USP-NF material. Fifteen fatty acids were separated using a DB-FFAP （nitroterephthalic acid modified polyethylene glycol） capillary GC column （30 m × 0.32 mm i.d.） with a total run time of 20 rain. The method was validated in terms of specificity, linearity, precision, accuracy, sensitivity, and robust- ness. The method can be routinely used for the purpose of oleic acid USP-NF material analysis.
Oleic acid is a common pharmaceutical excipient that has been widely used in various dosage forms. Gas chromatography （GC） has often been used as the quantitation method for fatty acids normally requiring a derivatization step. The aim of this study was to develop a simple, robust, and derivatization-free GC method that is suitable for routine analysis of all the major components in oleic acid USP-NF （United States Pharmacopeia-National Formulary） material. A gas chromatography-flame ionization detection （GC-FID） method was developed for direct quantitative analysis of oleic acid and related fatty acids in oleic acid USP-NF material. Fifteen fatty acids were separated using a DB-FFAP （nitroterephthalic acid modified polyethylene glycol） capillary GC column （30 m × 0.32 mm i.d.） with a total run time of 20 rain. The method was validated in terms of specificity, linearity, precision, accuracy, sensitivity, and robust- ness. The method can be routinely used for the purpose of oleic acid USP-NF material analysis.
