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 ame 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 modi ed polyethylene glycol) capillary GC column (30 m 0.32 mm i.d.) with a total run time of 20 min. The method was validated in terms of speci city, linearity, precision, accuracy, sensitivity, and robust- ness. The method can be routinely used for the purpose of oleic acid USP-NF material analysis.
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