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Abstract
Penggunaan Hidrokuinon dan Asam Retinoat pada produk kosmetik tanpa resep dokter tidak diizinkan menurut peraturan yang berlaku di Indonesia. Metode analisis yang tersedia saat ini masih menggunakan sistem HPLC yang dijalankan secara individual untuk masing-masing senyawa dan membutuhkan waktu analisis yang lama. Oleh karena itu, diperlukan pengembangan metode yang lebih cepat dan efisien. Pengembangan metode analisis identifikasi simultan Hidrokuinon dan Asam Retinoat dijalankan menggunakan Ultra High Performance Liquid Chromatography (UHPLC) dengan detektor PDA, kolom Hypersil GOLD® C18 (150 mm x 2.1 mm 3µm), fasa gerak metanol - asam format 0,1% dengan sistem gradien, laju alir 0,35 mL/menit dan dideteksi pada 290 nm untuk hidrokuinon dan 354 nm untuk asam retinoat. Parameter validasi yang dilakukan adalah selektivitas dan batas deteksi. Hasil validasi metode menunjukkan waktu retensi untuk hidrokuinon pada 1,93 menit dan untuk asam retinoat pada 11,99 menit. Tidak ada peak yang memberikan waktu retensi yang sama baik pada pelarut maupun larutan sampel. Persamaan kurva kalibrasi untuk hidrokuinon adalah y = 11591x + 1312 (r = 0.999) dan untuk asam retinoat adalah y = 37839x + 17732 (r = 0.999). Nilai batas deteksi dari hidrokuinon dan asam retinoat sebesar 5,92 µg/g dan 7,74 µg/g secara berurutan. Metode ini valid digunakan untuk analisis hidrokuinon dan asam retinoat pada sampel produk kosmetika, serta 67% cepat dan 90% lebih hemat fasa gerak dibandingkan metode yang tersedia saat ini.
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References
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- ASEAN. 2005. Identification of Retinoic Acid (Tretinoin) in Cosmetic Products by TLC and HPLC. ACM SIN 01: 3-5.
- Boonten, Jente, Matthias D’hondt, Lieselotte Veryser, Kathelijne Peremans, Christian Burvenich, dan Bart De Spiegeleer. 2013. A critical quality parameter in quantitative fused-core chromatography: The injection volume, Journal of Pharmaceutical Analysis. 3(5): 330-334.
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- Chawla, G., dan Ranjan, C. 2016. Principle, Instrumentation, And Applications of UPLC: A Novel Technique of Liquid chromatography. Open Chemistry Journal, 3(1): 1-16.
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- Food and Drug Administration. 1994. Reviewer Guidance Validation of Chromatographic Method, Center for Drug Evaluation and Research: Rockville, MD.
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- Mukhlesur, Rahman. 2018. Chapter 4 - Application of Computational Methods in Isolation of Plant Secondary Metabolites, Computational Phytochemistry. Amsterdam: Elsevier.
- Peraturan Badan Pengawas Obat dan Makanan Nomor 23 Tahun 2019 tentang Persyaratan Teknis Bahan Kosmetika
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- Rahmayuni, Elvi, Harmita Harmita, dan Herman Suryadi. 2018. Development and Validation Method for Simultaneous Analysis of Retinoic Acid, Hydroquinone and Corticosteroid in Cream Formula by High-Performance Liquid Chromatography. Journal of Applied Pharmaceutical Science,8(09): 087-092.
- Snyder, Lloyd R., Joseph J. Kirkland, dan Joseph L. Glajch. 1997. Practical HPLC Method Development. New Jersey: John Wiley & Sons, Inc.
- Swartz, Michael. 2010. Hplc Detectors: A Brief Review. Journal of Liquid Chromatography & Related Technologies, 33:1130–1150.
- U.S. Pharmacopeia. 2006. The United States Pharmacopeia, USP 29/The National Formulatory, NF 34. Rockville, MD: U.S. Pharmacopeial Convention, Inc., 3050.
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References
ASEAN. 2005. Identification and Determination of Hydroquinone in Cosmetic Products by TLC and HPLC. ACM INO 03: 3-5.
ASEAN. 2005. Identification of Retinoic Acid (Tretinoin) in Cosmetic Products by TLC and HPLC. ACM SIN 01: 3-5.
Boonten, Jente, Matthias D’hondt, Lieselotte Veryser, Kathelijne Peremans, Christian Burvenich, dan Bart De Spiegeleer. 2013. A critical quality parameter in quantitative fused-core chromatography: The injection volume, Journal of Pharmaceutical Analysis. 3(5): 330-334.
Chesnut, Stephen M. dan Salisbury, John J. 2007. The role of UHPLC in pharmaceutical development. Journal of Separation Science, 30: 1183 – 1190
Chawla, G., dan Ranjan, C. 2016. Principle, Instrumentation, And Applications of UPLC: A Novel Technique of Liquid chromatography. Open Chemistry Journal, 3(1): 1-16.
de la Guardia, M. dan Armenta, S. 2011. Chapter 7 - Downsizing the Methods, Comprehensive Analytical Chemistry. Oxford: Elsevier
Desmedt, B., P. Courselle, J.O. De Beer, V. Rogiers, M. Grosber, E. Deconinck, dan K. De Paepe. 2016. Overview of skin whitening agents with an insight into the illegal cosmetic market in Europe, Journal of European Academy of Dermatology and Venereology, 30: 943–950.
Food and Drug Administration. 1994. Reviewer Guidance Validation of Chromatographic Method, Center for Drug Evaluation and Research: Rockville, MD.
Gimeno, Pascal, Annie-Françoise Maggio, Marjorie Bancilhon, Nelly Lassu, Hervé Gornes, Charlotte Brenier, dan Laurent Lempereur. 2016. HPLC–UV Method for the Identification and Screening of Hydroquinone, Ethers of Hydroquinone and Corticosteroids Possibly Used as Skin-Whitening Agents in Illicit Cosmetic Products. Journal of Chromatographic Science, 54(3): 343–352
International Conference on Harmonization (ICH). (1995). Validation of Analytical Procedures: Text and Methodology Q2(R1). Geneva: International Conference on Harmonization.
Mazroatul, Linda, Annisa Ananda Ulya, Supandi, dan Umar Mansur. 2019. Analytical Methods Validation of Retinoic Acid and Hydroquinone Using Ultra High Performance Liquid Chromatography in Medicinal Cream. Pharmaceutical and Biomedical Sciences Journal, 1(1): 7-12
Mukhlesur, Rahman. 2018. Chapter 4 - Application of Computational Methods in Isolation of Plant Secondary Metabolites, Computational Phytochemistry. Amsterdam: Elsevier.
Peraturan Badan Pengawas Obat dan Makanan Nomor 23 Tahun 2019 tentang Persyaratan Teknis Bahan Kosmetika
Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.23.08.11.07331 Tahun 2011 tentang Metode Analisis Kosmetika
Rahmayuni, Elvi, Harmita Harmita, dan Herman Suryadi. 2018. Development and Validation Method for Simultaneous Analysis of Retinoic Acid, Hydroquinone and Corticosteroid in Cream Formula by High-Performance Liquid Chromatography. Journal of Applied Pharmaceutical Science,8(09): 087-092.
Snyder, Lloyd R., Joseph J. Kirkland, dan Joseph L. Glajch. 1997. Practical HPLC Method Development. New Jersey: John Wiley & Sons, Inc.
Swartz, Michael. 2010. Hplc Detectors: A Brief Review. Journal of Liquid Chromatography & Related Technologies, 33:1130–1150.
U.S. Pharmacopeia. 2006. The United States Pharmacopeia, USP 29/The National Formulatory, NF 34. Rockville, MD: U.S. Pharmacopeial Convention, Inc., 3050.
Westerhof, W. dan Kooyers, T. J. 2005. Hydroquinone and its analogues in dermatology – a potential health risk, Journal of Cosmetic Dermatology. 4(2): 55-59.