Abstract
Anew method for quantitative determination of the active ingredient in phenyl salicylate drug substance using gas chromatography with flame-ionization detection (GC-FID) was developed and validated. The experiments used an HP-5 quartz capillary column with a grafted stationary phase of diphenyl- (5%) and dimethylpolysiloxane (95%) (Agilent Technologies, USA). The conditions for the chromatographic separation and the chromatography system suitability parameters were determined. The phenyl salicylate content in the drug substance was determined by the internal standard method. The method was validated for specificity, linearity, precision, and stability (robustness) and was found to meet the main acceptance criteria.
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