A new and rapid HPLC method for the determination of phenoxyethanol in topical formulation

OpenAlex İngilizce

Background and Aims: This study develops and validates a new liquid chromatographic method for determining the phenoxyethanol used as an antimicrobial preservative in pharmaceutic and cosmetic products. The study applies the developed high-performance liquid chromatography (HPLC) method to pomade formulation using a diode array detector to determine the phenoxyethanol.Methods: The phenoxyethanol in the sample was analyzed in a C18 column (150 x 4.6 mm, 5 µm ID) under chromatographic conditions where the flow rate was determined as 1.0 mL/min. The column oven was 30.0°C, and phenoxyethanol was detected at 270 nm. Isocratic application of acetonitrile-water (50:50, v/v) was used as the mobile phase system. The validation of the developed method was performed according to the guidelines from the International Conference on Harmonisation (ICH, 2005) Guidelines Q2 (R1).Results: The linearity range of the phenoxyethanol was 0.125-0.375 mg/mL, and the limits of detection and quantification were calculated as 31.25 ng/mL and 125.0 ng/mL, respectively. The assay recovery and precision of the phenoxyethanol from the pomade formulation were evaluated at 0.125 mg/mL, 0.250 mg/mL, and 0.375 mg/mL concentrations. The mean recoveries for phenoxyethanol in the pomade formulation were calculated at 99.99%-102.86%.Conclusion: The validated method was successfully applied for determining phenoxyethanol in a topical formulation. The proposed method is cheap, fast, and simple and can be used safely for routine analysis.