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

Year 2024, , 96 - 101, 30.04.2024

Gamze Ergin Kızılçay , Sıdıka Toker , Dilek Matur

https://doi.org/10.26650/IstanbulJPharm.2024.1385171

Abstract

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.

Keywords

Phenoxyethanol, HPLC, DAD, cream formulation, validation, antimicrobial preservative

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