Development of HPLC method for phenylethyl resorcinol content determination in whitening cream preparation

Abstract

This experiment aimed to develop and validate an analytical method using HPLC for phenylethyl resorcinol (PR) content determination in the emulsion-cream formula, consisted five preservative agents methylparaben, ethylparaben, propylparaben, butylparaben, and phenoxyethanol. Measurement was carried out with a UV detector and using a C18 column. Previously, a selectivity test was conducted to distinguish PR from the other whitening agents that were hydroquinone, alpha-arbutin, kojic acid, and vitamin C. The mobile phase system was optimized by using acetonitrile, water, and methanol, in a gradient concentration. The optimum condition was set in the flow rate of 1.0 mL/min, which provided a suitable chromatogram. Linearity in the range of 10.48-73.36 mg/mL showed a correlation coefficient (r) = 0.9999 and generated the detection and quantification limit of 0.7183 mg/L and 2.3943 mg/L, respectively. A robustness test was performed by a variate internal and external factor changes also proved the proper precision. Finally, the validated method was applied as an adequate quantitative analysis to determining phenyl ethyl resorcinol content in the whitening cream preparations.

Keywords

• : Phenyl ethyl resorcinol
• preservatives
• whitening cream
• HPLC
• reverse phase
• gradient mobile phase
• validation method

References

1. [1] Shankar PV, Subish P. Fair skin in South Asia: an obsession? J Pakistan Assoc Derma. 2007; 17: 100-104.
2. [2] Marway H. Should we genetically select for the beauty norm of fair skin? Health Care Anal. 2018; 26: 246-268. [CrossRef]
3. [3] Shroff H, Diedrichs PC, Craddock N. Skin color, cultural capital, and beauty products: an ınvestigation of the use of skin fairness products in Mumbai, India. Front Public Health. 2017; 5: 365. [CrossRef]
4. [4] Maqsood S. Role of media in glorifying white complexion. Sci Int (Lahore). 2015; 27: 6249-6253.
5. [5] International Trade Administration. Asia Personal Care and Cosmetics Market Guide, Department of Commerce, USA, 2016. https://www.trade.gov/industry/materials/AsiaCosmeticsMarketGuide.pdf (accessed July 10, 2019).
6. [6] Young JA. 2-Propanol. J Chem Educ. 2008; 85: 1186. [CrossRef]
7. [7] Kong K, Ren X, Qi J, Yu J, Lu J, Wang S. Carbon-carbon double bond and resorcinol in resveratrol and ıts analogues: what ıs the characteristic structure in quenching singlet oxygen? Biomolecules. 2019; 9(7):268. [CrossRef]
8. [8] Kim BS, Na YG, Choi JH, Kim I, Lee E, Kim SY, Lee JY, Cho CW. The ımprovement of skin whitening of phenyl ethyl resorcinol by nanostructured lipid carriers. Nanomaterials. 2017; 7(9): 241. [CrossRef],

9. [9] Resorcinol, 2019. https://www.ewg.org/skindeep/ingredient/705539/resorcinol/ [accessed August 12, 2019].
10. [10] Yates RL, Havery DC. Determination of phenol, resorcinol, salicylic acid, and α-hydroxy acids in cosmetic products and salon preparations. Int J Cosmet Sci. 1999; 50: 315-325.
11. [11] Love A, Kerschner J, Barratt M, Zhou Y. Stabilization of resorcinol derivatives in cosmetic compositions. US Patent US20030180234A1, Conopco Inc, Unilever Home and Personal Care, USA, 2003. https://patents.google.com/patent/US20030180234 [accessed August 18, 2019].
12. [12] New Zealand Trade & Enterprise. China Regulatory Newsletter: 2012 Review on Cosmetics and Skincare, Natural Health Products NZ, New Zealand, 2012: 1-32. https://www.naturalhealthproducts.nz/wpcontent/uploads/2013/04/China-Regulatory-Newsletter-Cosmetics-2012.pdf [accessed August 18, 2019].
13. [13] Hong L, Han D, Li MX, Zhang P, Liu CG. Development and validation of an ultraviolet–visible spectrophotometric method for determination of phenylethyl resorcinol in new topical nanoemulsions. Int J Cosmet Sci. 2017; 39(3): 337- 343. [CrossRef]
14. [14] Limsuwan T, Boonme P, Amnuaikit T. The optimized HPLC method for quantitative analysis of phenylethyl resorcinol loaded in the novel vesicle carriers and permeated in ın vitro skin permeation study. J Chromatogr Sci. 2017; 55(10): 992–999. [CrossRef]
15. [15] Li L, Run Y. Determination of content of phenylethyl resorcinol in whitening and freckle-removing cosmetics by HPLC. Jiangsu J Prev Med. 2014; 5.
16. [16] Ramos JC, Bohórquez VM, Real MV, Castro CM, Cernicka D, Orland AF, Fernandez MC. HPLC method development and validation to determinate resorcinol for quality control in pharmaceutical formulations. Eur J Hosp Pharm. 2018; 25, A28-A29. [CrossRef]
17. [17] De AK, Chowdury PP, Chattapadhyay S. Quantitative analysis of resorcinol from marketed hair tonic using liquid chromatographic technique. Int Sch Res Notices. 2014; 632591. [CrossRef]
18. [18] Rastogi SC. A method for the analysis of intermediates of oxidative hair dyes in cosmetic products. J Sep Sci. 2014; 24(3): 173-178. [CrossRef]
19. [19] DrugBank, Phenylethyl Resorcinol, 2019. https://www.drugbank.ca/drugs/DB14120 [accessed August 18, 2019].
20. [20] United State Pharmacopeia and National Formulary. The United State Pharmacopeia. Rockville, MD: U.S. Pharmacopeia Convention. USP 32–NF 27, 2009 <621>.
21. [21] International Conference on Harmonization (ICH), ICH Q2 Validation of analytical procedures: text and methodology international conference on harmonization of technical requirements for registration of pharmaceutical for human use, ICH Harmonized, Tripartite Guideline, Canada, 2005. https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf [accessed January 12, 2020].
22. [22] AOAC International. Appendix F: Guidelines for Standard Methods Performance Requirements. AOAC Official Method of Analysis AOAC International, 2016: 1-18.
23. [23] Ahuja S, Dong, MW. Handbook of Pharmaceutical Analysis by HPLC. Elsevier, The Netherlands, 2005, pp. 20-25.
24. [24] Ehmer J, Miller JH, Method Validation in Pharmaceutical Analysis: A Guide to Best Practice. Wiley-VCH, Weinheim, Germany, 2005.
25. [25] Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm. 2015; 5: 7-19.
26. [26] Horwitz W, Albert R. The Horwitz ratio (HorRat): A useful index of method performance with respect to precision. J AOAC Int. 2006; 89: 1095-1109.
27. [27] Bliesner, DM. Validating Chromatographic Methods: A Practical Guide. A John Wiley & Sons, USA, 2006.
28. [28] Hendriks MMWB, De Boer JH, Smilde AK (Eds.). Robustness of Analytical Methods and Pharmaceutical Technologycal Product. Elsevier Science BV, Amsterdam, Netherlands, 1996.
29. [29] Batrawi N, Wahdan S, Abualhasan M. Analytical method validation of high-performance liquid chromatography and stability-ındicating study of medroxyprogesterone acetate ıntravaginal sponges. Anal Chem Insights. 2017; 12: 1177390117690152. [CrossRef]
30. [30] Nugrahani I, Manosa EY, Cintya L. FTIR-derivatives as a green method for simultaneous content determination of caffeine, paracetamol, and acetosal in tablet compared to HPLC. Vib Spectrosc. 2019; 104: 102941. [CrossRef]
31. [31] Pandis N. Comparison of 2 means (independent z test or independent t test). Am J Orthod Dentofacial Orthop. 2015; 148(2): 350-351. [CrossRef]
32. [32] Skaik Y. The bread and butter of statistical analysis “t-test”: uses and misuses. Pak J Med Sci. 2015; 31(6): 1558–1559. [CrossRef]