SIMULTANEOUS IDENTIFICATION AND QUANTIFICATION OF HYDROQUINONE, TRETINOIN AND BETAMETHASONE IN COSMETIC PRODUCTS BY ISOCRATIC REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

  • baitha maggadani Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
  • harmita harmita Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
  • yahdiana harahap Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia
  • hanna hutabalian Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia

Abstract

Objective: The objective of this study was to obtain a simple and selective analysis method for determination of hydroquinone, tretinoin and betamethasone in whitening creams using reversed phase high-performance liquid chromatography (HPLC).


Methods: Reverse Phase HPLC was used for method development, validation studies, and sample analysis. The method was optimized by evaluating several parameters that affects extraction of the sample, composition and types of mobile phase and also flow rate. Chromatographic separation was optimized on a C18 column [Sunfire, 250 x 4.6 mm, 5µm] utilizing a mobile phase consisting acetonitrile, methanol (90:10 v/v) and slightly addition of glacial acetic acid to reach pH 5in the ratio of 30: 50:20 v/v at a flow rate of 0.8 ml/min with UV detection at 270 nm and 350 nm.


Results: The analytical methods fulfilled the validation requirements including accuracy, precision, linearity, selectivity, detection limits, and quantitation limits. The results showed the mean levels of hydroquinone, tretinoin and betamethasone in samples A and B were 1.78%; 0.07%; 0.12% and 2.00%; 0.07%; 0.13% respectively.


Conclusion: The method was successfully applied for the determination of cosmetic formulation containing hydroquinone, tretinoin and betamethasone simultaneously. There were seven samples analyzed and two samples were positive containing hydroquinone, tretinoin, and betamethasone.

Keywords: hydroquinone, tretinoin, betamethasone, whitening cream, HPLC reversed phase, optimization, validation

Author Biographies

harmita harmita, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia

lecturer in Faculty of Pharmacy Universitas Indonesia

yahdiana harahap, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia

lecturer in faculty of pharmacy universitas indonesia

References

1. Lewis KM, Gaska K, Robkin N, Martin A, Andrews E, Williams J. The need for interventions to prevent skin bleaching. J Black Stud 2012;43:787-805.
2. Mahé A, Perret JL, Ly F, Fall F, Rault JP, Dumont A. The cosmetic use of skin-lightening products during pregnancy in Dakar, Senegal: a common and potentially hazardous practice. Trans R Soc Trop Med Hyg 2007;101:183-7.
3. Petit A, Cohen-Ludmann C, Clevenbergh P, Bergmann JF, Dubertret L. Skin lightening and its complications among African people living in Paris. J Am Acad Dermatol 2006 ;55:873-8.
4. Bocca B, Pino A, Alimonti A, Forte G. Toxic metals contained in cosmetics: a status report. Regul Toxicol Pharmacol 2014 ;68:447-67.
5. al-Saleh I, al-Doush I. Mercury content in skin-lightening creams and potential hazards to the health of Saudi Women. J Toxicol Environ Health. 1997;51:123-30.
6. Desmedt B, Rogiers V, Courselle P, De Beer JO, De Paepe K, Deconinck E. Development and validation of a fast chromatographic method for screening and quantification of legal and illegal skin whitening agents. J Pharm Biomed Anal. 2013 ;83:82-8.
7. Badan Pengawas Obat dan Makanan Republik Indonesia. Surat Edaran Nomor PO.02.05.43.4496 Tentang Produk Kosmetik yang Mengandung Hidrokinon, 2008
8. Astuti D, Prasetya H, & Irsalina D. Identifikasi hidroquinon pada krim pemutih wajah yang dijual di minimarket wilayah Minomartani, Yogyakarta. 2016: 2:1.
9. Irnawati I, Sahumena MH, Dewi WON. Analisis hidrokuinon pada krim pemutih wajah dengan metode spektrofotometer UV-VIS. Pharmacon: Jurnal Ilmiah Farmasi – UNSRAT 2016;5:229-237.
10. Anand K & Pandey A. Validation Study of Steroidal Drugs (Dexamethasone And Betamethasone) By U.V. Spectrophotometric Method. Asian J Pharm Clin Res, 2018; 11: 501-505
11. Gianti G. Analisis kandungan merkuri dan hidrokuinon dalam kosmetik krim racikan dokter. Skripsi, Fakultas Kedokteran dan Ilmu Kesehatan, UIN Syarif Hidayatullah, Jakarta, Indonesia. 2013.
12. Tashtoush BM, Jacobson EL, Jacobson MK. A rapid HPLC method for simultaneous determination of tretinoin and isotretinoin in dermatological formulations. J Pharm Biomed Anal. 2007;43:859-6.
13. Chisvert A, Sisternes J, Balaguer A & Salvador. A gas chromatography-mass spectrometric method to determine skin-whitening agents in cosmetic products. Talanta 2010; 81:530-6
14. Skoog DA, Holler FJ, Crouch SR. Principles of instrumental analysis. 6th ed. Belmont, CA: Thomson, Brooks/Cole; 2007.
15. ICH. ICH Harmonised Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonization; 1994(November 1996). Geneva, Switzerland: ICH; 2005. 17p. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
16. Desmedt B, Rogiers V, Courselle P, De Beer J, De Paepe K, & Deconinck E. Development and validation of a fast chromatographic method for screening and quantification of legal and illegal skin whitening agents. J Pharm Biomed Anal 2013; 83: 82-88.
17. Chang, M., & Chang, C. Simultaneous HPLC determination of hydrophilic whitening agents in cosmetic products. J Pharm Biomed Anal 2003; 33: 617-626.
18. Disdier, B, Bun H, Catalin J., & Durand, A. Simultaneous determination of all-trans-, 13-cis-, 9-cis-retinoic acid and their 4-oxo-metabolites in plasma by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 1996; 683:143-154.
19. Gao, W, & Legido-Quigley, C. Fast and sensitive high performance liquid chromatography analysis of cosmetic creams for hydroquinone, phenol and six preservatives. J Chromatogr A 2011;1218: 4307-4311.
20. Li S, Tian M, Row KH. Effect of mobile phase additives on the resolution of four bioactive compounds by RP-HPLC. Int J Mol Sci. 2010; 11: 2229–2240
21. Badan Pengawas Obat dan Makanan Republik Indonesia. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor HK.03.1.23.08.11.07331 Tentang Metode Analisis Kosmetika. Jakarta 2011
22. Badan Pengawas Obat dan Makanan Republik Indonesia. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia Nomor HK.03.1.23.12.11.10052 Tentang Pengawasan Produksi dan Peredaran Kosmetika. Jakarta. 2011
Statistics
106 Views | 122 Downloads
How to Cite
maggadani, baitha, harmita, harmita, harahap, yahdiana, & hutabalian, hanna. (2019). SIMULTANEOUS IDENTIFICATION AND QUANTIFICATION OF HYDROQUINONE, TRETINOIN AND BETAMETHASONE IN COSMETIC PRODUCTS BY ISOCRATIC REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY. International Journal of Applied Pharmaceutics, 11(3), 181-185. https://doi.org/10.22159/ijap.2019v11i3.32297
Section
Original Article(s)