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

Yıl 2024, Cilt: 54 Sayı: 1, 96 - 101, 30.04.2024

Gamze Ergin Kızılçay , Sıdıka Toker , Dilek Matur

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

Öz

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.

Anahtar Kelimeler

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

Kaynakça

• Abad-Gil, L., Lucas-Sanchez, S., Gismera, M.J., Sevilla, M.T., & Pro-copio, J.R. (2021). Determination of paraben-, isothiazolinone-and alcohol-type preservatives in personal care products by HPLC with dual (diode-array and fluorescence) detection. Microchemi-cal Journal, 160, 105613. doi:/10.1016/j.microc.2020.105613 google scholar
• Abad-Gil, L., Lucas-Sanchez, S., Gismera, M.J., Sevilla, M.T., & Procopio, J.R. (2022). HPLC method with electrochemical detec-tion on gold electrode for simultaneous determination of different antimicrobial agents in cosmetics. Microchemical Journal, 182, 107881. doi:10.1016/j.microc.2022.107881 google scholar
• Akhtar, M. J., Khan, S., Roy, I.M., & Jafri, I.A. (1996). High performance liquid chromatographic determination of phenoxe-tol, methyl paraben, ethyl paraben, n-propyl paraben, iso-butyl paraben, n-butyl paraben and croconazole" HC1. Journal of Phar-maceutical and Biomedical Analysis, 14, 1609-1613. google scholar
• Algethami, F.K., AlSalem H. S., Gamal, M., Nabil, N., Zaazaa, H. E., Ibrahim, M. A., & Mandour, A. A. (2023). Simultaneous Analysis of Flumethasone Pivalate and Clioquinol in the Presence of Phenoxyethanol Preservative in Their Pharmaceuticals Using TLC and UHPLC Methods. Processes 11, 1888-1901. doi :10.3390/pr11071888 google scholar
• ANSM/ FEBEA, Risk assessment on the use of phenoxyethanol in cosmetic products (2012), ansm.sante.fr/var/ansm_site/storage/original/application/0b46fedc 079e8bb174a40b7b6f16d04c.pdf google scholar
• ANSM, A mandatory warning on leave-on cosmetics containing phenoxyethanol (2019),ansm.sante.fr/content/download/158253/2075101/version /1/file/DPS_Phenoxyethanol-200319.pdf google scholar
• Borremans, M., Loco, V.J., Roos, P., & Goeyens, L. (2004). Valida-tion of HPLC Analysis of 2-Phenoxyethanol, 1-Phenoxypropan-2-ol, Methyl, Ethyl, Propyl, Butyl and Benzyl 4-Hydroxybenzoate (Parabens) in Cosmetic Products, with Emphasis on Decision Limit and Detection Capability. Chromatographia, 59, 47-53.doi:10.1365/s10337-003-0127-2 google scholar
• Dreno, B., Zuberbier, T., Gelmetti, C., Gontijo, G., & Marinovich, M. (2019). Safety review of phenoxyethanol when used as a preser-vative in cosmetics. Journal of the European Academy of Derma-tology & Venereology, 33 (7), 15-24. doi: 10.1111/jdv.15944. google scholar
• ICH Q2 (R1). (2005). Validation of Analytical Procedures: Text and Methodology, https://database.ich.org/sites/default/files/Q2%28R1%29%20 Guideline.pdf.Accessed October 8, 2023. google scholar
• Jakubczykz, M., & Michalkiewicz, S. (2019). First Voltammetric Method of Phenoxyethanol Determination in Pharmaceutical and Cosmetic Preparations. Journal of The Electrochemical Society, 166 (8) 291-296. doi:10.1149/2.05219008jes google scholar
• Regulation (EC) No 1223/2009 of The European Parliament and of the Council of 30 November 2009 on Cosmetic Products (Dz. U. L 342/59 of 22.12.2009 r.). google scholar
• Roy, C., & Chakrabarty, J. (2013). Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous De-termination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceuti-cal Dosage Formulation, Scientia Pharmaceutica. 81, 951-967. doi:10.3797/scipharm.1303-22. google scholar
• Shabir, G.A. (2010). A New Validated HPLC Method for the Si-multaneous Determination of 2-phenoxyethanol, Methylparaben, Ethylparaben and Propylparaben in a Pharmaceutical Gel. Indian Journal of Pharmaceutical Sciences, 72 (4): 421-425. google scholar
• Sharma, B., Joseph, A., & Sood, A. (2008). A simple and rapid method for quantifying 2-phenoxyethanol (2-PE) in Diphtheria, Tetanus and w-Pertussis (DTwP) vaccine. Biologicals 36: 61-63. google scholar