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Abstract
Abstract
Background: The COVID-19 pandemic had caused the consumption of vitamins in the community to increase with the aim of maintaining immunity in the body.
Objective: This study aims to develop an analysis method with a UV-Vis spectrophotometer, which is considered an alternative analysis method that is easier, more practical, and cheaper.
Method: Methods for analyzing alpha-tocopherol acetate are validated through specificity tests, linearity measurements, precision tests, accuracy tests, determination of detection limits, determination of quantitation limits, and determination of range using ethanol p.a solvent and UV-Vis Spectrophotometer instruments. Then, examine the alpha tocopherol acetate content of vitamin E dietary supplements.
Results: The specificity test showed that matrix had no significant effect on the analysis, the linearity test met the requirements with a concentration range of 20–60 ug/mL (r = 0.9991), the accuracy test was 99.897-100.315%, intraday and interday precision tests were obtained with %RSD less than 2%, the LOD value was 1.859 ug/mL and the LOQ value was 5.635 ug/mL. The determination of levels of vitamin E in dietary supplements showed levels for brand A of 100.508% and brand B of 100.089%.
Conclusion: The analytical method developed had met the validation requirements, and the levels of vitamin E food supplements had met the USP requirements.
Keywords: method validation, UV-Vis spectrophotometer, alpha tocopherol acetate
Intisari
Latar belakang: Pandemi COVID-19 menyebabkan penggunaan vitamin di masyarakat meningkat dengan tujuan agar imunitas pada tubuh tetap terjaga.
Tujuan: Mengembangkan dan memvalidasi metode analisis vitamin E dengan tujuan uji kualitatif dan kuantitatif menggunakan spektrofotometer UV-Vis yang dinilai sebagai metode analisis alternatif yang lebih mudah, praktis, dan murah.
Metode: Validasi metode yang dilakukan untuk analisis senyawa alfa tokoferol asetat meliputi uji spesifisitas, pengukuran linieritas, uji presisi, uji akurasi, penentuan limit deteksi, penentuan limit kuantifikasi, dan penentuan rentang menggunakan pelarut etanol p.a. dan alat spektrofotometer UV-Vis. Metode yang telah memenuhi kriteria validasi kemudian digunakan untuk pengecekan kadar kandungan alfa tokoferol asetat dalam suplemen vitamin E.
Hasil: Penelitian ini memberikan hasil yaitu matriks tidak teranalisis pada uji spesifisitas, uji linieritas telah memenuhi syarat dengan rentang konsentrasi 20–60 ug/mL (r2= 0,9991), uji akurasi 99,897-100,315%, uji presisi interday dan intraday didapatkan hasil %RSD kurang dari 2%, nilai LOD 1,859 ug/mL dan nilai LOQ 5,635 ug/mL. Penetapan kadar sediaan vitamin E telah memenuhi ketentuan yaitu 100,508% dan 100,089%.
Kesimpulan: Metode yang dikembangkan telah memenuhi ketentuan validitas dan kadar vitamin E pada sampel sesuai dengan ketentuan USP.
Kata kunci: validasi metode, spektrofotometer UV-Vis, alfa tokoferol asetat
Keywords
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
References
- FDA. (2016). Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-converting-units-measure-folate-niacin-and-vitamins-d-and-e-nutrition-and
- Fithriyah, N. (2013). Analisis α-Tokoferol (Vitamin E) pada Minyak Biji Kelor (Moringa Oleifera Lam.) secara Kromatografi Cair Kinerja Tinggi. Skripsi, UIN Syarif Hidayatullah Jakarta: Jakarta.
- Harborne, J. B. (1987). Metode fitokimia: Penuntun Cara Modern Menganalisis Tumbuhan (Vol. 78). Bandung: Penerbit ITB.
- Harmita, H. (2004). Petunjuk Pelaksanaan Validasi Metode dan Cara Perhitungannya. Majalah Ilmu Kefarmasian, 1(3), 117-135. doi:http://doi.org/10.7454/psr.v1i3.3375
- ICH. (2021). Validation of Analytical Procedures Q2(R2). European Medicines Agency. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf
- Iddir, M., Brito, A., Dingeo, G., Del Campo, S. S., Samouda, H., La Frano, M. R., & Bohn, T. (2020). Strengthening the Immune System and Reducing Inflammation and Oxidative Stress through Diet and Nutrition: Considerations during the COVID-19 Crisis. Nutrients, 12(6). doi:https://doi.org/10.3390/nu12061562
- Irawati, L. (2011). Validasi Metode Spektrofluorometri untuk Penentuan Alfa Tokoferol dalam Minyak Jagung. Politeknik Negeri Ujung pandang, Makassar.
- Jovic, T. H., Ali, S. R., Ibrahim, N., Jessop, Z. M., Tarassoli, S. P., Dobbs, T. D., Holford, P., Thornton, C. A., & Whitaker, I. S. (2020). Could vitamins help in the fight against COVID-19? Nutrients, 12(9), 2550. doi:https://doi.org/10.3390/nu12092550
- Kemenkes_RI. (2020). Farmakope Indonesia, Edisi IV. Jakarta: Kementerian Kesehatan Republik Indonesia.
- Lee, G. Y., & Han, S. N. (2018). The Role of Vitamin E in Immunity. Nutrients, 10. doi:https://doi.org/10.3390/nu10111614.
- Ng, M. H., & May, C. Y. (2012). Analisis Kromatografi Tokoferol dan Tokotrienol dalam Minyak Kelapa Sawit. Jurnal Ilmu Kromatografi 50(3), 283-286. doi:https://doi.org/10.1093/chromsci/bms002
- Prabowo, M. H., Wibowo, A., & Fauziyah, L. (2012). Pengembangan dan Validasi Metode Analisis Rifampicin Isoniazid-pirazinamid dalam Fixed Dose Combination dengan Metode Kromatografi Lapis Tipis-Densitometri. Jurnal Ilmiah Farmasi, 9(2). doi:https://doi.org/10.20885/jif.vol9.iss2.art4
- Shakoor, H., Feehan, J., Al Dhaheri, A. S., Ali, H. I., Platat, C., Ismail, L. C., Apostolopoulos, V., & Stojanovska, L. (2021). Immune-boosting Role of Vitamins D, C, E, zinc, Selenium and Omega-3 Fatty Acids: Could They Help Against COVID-19? Maturitas, 143, 1-9. doi:https://doi.org/10.1016/j.maturitas.2020.08.003
- Sunaric, S., Lalic, j., & Spasic, A. (2017). Simultaneous Determination of Alpha-Tocopherol and Alpha-Tocopheryl Acetate in Dairy Products, Plant Milks and Health Supplements by Using SPE and HPLC Method. Food Analytical Methods, 10, 1-16. doi:https://doi.org/10.1007/s12161-017-0943-x
- Traber, M. G. (2007). Vitamin E Regulatory Mechanisms. Annu. Rev. Nutrients, 27, 347-362.
- USP. (2018). The United States Pharmacopeia 44 - NF 36. U.S. Pharmacopeial Convention Inc, Rockville, p.6459-6460.
References
FDA. (2016). Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-converting-units-measure-folate-niacin-and-vitamins-d-and-e-nutrition-and
Fithriyah, N. (2013). Analisis α-Tokoferol (Vitamin E) pada Minyak Biji Kelor (Moringa Oleifera Lam.) secara Kromatografi Cair Kinerja Tinggi. Skripsi, UIN Syarif Hidayatullah Jakarta: Jakarta.
Harborne, J. B. (1987). Metode fitokimia: Penuntun Cara Modern Menganalisis Tumbuhan (Vol. 78). Bandung: Penerbit ITB.
Harmita, H. (2004). Petunjuk Pelaksanaan Validasi Metode dan Cara Perhitungannya. Majalah Ilmu Kefarmasian, 1(3), 117-135. doi:http://doi.org/10.7454/psr.v1i3.3375
ICH. (2021). Validation of Analytical Procedures Q2(R2). European Medicines Agency. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf
Iddir, M., Brito, A., Dingeo, G., Del Campo, S. S., Samouda, H., La Frano, M. R., & Bohn, T. (2020). Strengthening the Immune System and Reducing Inflammation and Oxidative Stress through Diet and Nutrition: Considerations during the COVID-19 Crisis. Nutrients, 12(6). doi:https://doi.org/10.3390/nu12061562
Irawati, L. (2011). Validasi Metode Spektrofluorometri untuk Penentuan Alfa Tokoferol dalam Minyak Jagung. Politeknik Negeri Ujung pandang, Makassar.
Jovic, T. H., Ali, S. R., Ibrahim, N., Jessop, Z. M., Tarassoli, S. P., Dobbs, T. D., Holford, P., Thornton, C. A., & Whitaker, I. S. (2020). Could vitamins help in the fight against COVID-19? Nutrients, 12(9), 2550. doi:https://doi.org/10.3390/nu12092550
Kemenkes_RI. (2020). Farmakope Indonesia, Edisi IV. Jakarta: Kementerian Kesehatan Republik Indonesia.
Lee, G. Y., & Han, S. N. (2018). The Role of Vitamin E in Immunity. Nutrients, 10. doi:https://doi.org/10.3390/nu10111614.
Ng, M. H., & May, C. Y. (2012). Analisis Kromatografi Tokoferol dan Tokotrienol dalam Minyak Kelapa Sawit. Jurnal Ilmu Kromatografi 50(3), 283-286. doi:https://doi.org/10.1093/chromsci/bms002
Prabowo, M. H., Wibowo, A., & Fauziyah, L. (2012). Pengembangan dan Validasi Metode Analisis Rifampicin Isoniazid-pirazinamid dalam Fixed Dose Combination dengan Metode Kromatografi Lapis Tipis-Densitometri. Jurnal Ilmiah Farmasi, 9(2). doi:https://doi.org/10.20885/jif.vol9.iss2.art4
Shakoor, H., Feehan, J., Al Dhaheri, A. S., Ali, H. I., Platat, C., Ismail, L. C., Apostolopoulos, V., & Stojanovska, L. (2021). Immune-boosting Role of Vitamins D, C, E, zinc, Selenium and Omega-3 Fatty Acids: Could They Help Against COVID-19? Maturitas, 143, 1-9. doi:https://doi.org/10.1016/j.maturitas.2020.08.003
Sunaric, S., Lalic, j., & Spasic, A. (2017). Simultaneous Determination of Alpha-Tocopherol and Alpha-Tocopheryl Acetate in Dairy Products, Plant Milks and Health Supplements by Using SPE and HPLC Method. Food Analytical Methods, 10, 1-16. doi:https://doi.org/10.1007/s12161-017-0943-x
Traber, M. G. (2007). Vitamin E Regulatory Mechanisms. Annu. Rev. Nutrients, 27, 347-362.
USP. (2018). The United States Pharmacopeia 44 - NF 36. U.S. Pharmacopeial Convention Inc, Rockville, p.6459-6460.