Development and Validation of a RPLC Method for the Determination of 2-Phenoxyethanol in Senselle Lubricant Formulation.

A new and simple reversed-phase liquid chromatographic method has been developed and validated for the determination of 2-phenoxyethanol preservative (0.3%, w/w) in senselle lubricant formulation. The separation was achieved with acetonitrile-tetrahydrofuran-water (21:13:66, v/v/v) as mobile phase, a C(8) column, and UV detection at 258 nm. The calibration curve is linear (r(2)= 0.9999) from 20-140% of the analytical concentration of 0.75 mg/ml. The mean percent relative standard deviation values for intra- and inter-day precision studies are <1%. The recovery of 2-phenoxyethanol ranged between 99.76 and 100.03% from lubricant formulation. The limits of detection and quantitation are determined to be 0.094 and 0.15 mg/ml, respectively. The method was found to be robust and can be successfully and reliably used to determine the 2-phenoxyethanol preservative content of marketed formulations.