Farmasötik Yumuşak Kapsülde α-Tokoferolün Spektrofotometri ile Kantitatif Tayini

Abstract

Amaç: E vitamini sağlıklı durumun korunması ve hastalıkların önlenmesi için gerekli bir mikro besin maddesidir. Bu çalışmanın amacı, farmasötik preparatlarda α-tokoferolün belirlenmesi için basit, duyarlı ve kolayca uygulanabilir bir spektrofotometrik yöntem geliştirmek ve doğrulamaktır. Gereç ve Yöntem: Farmasötik preparatlarda α-tokoferolün kantitatif tayini 290 nm’de ölçülen maksimum absorbans değeri kullanılarak gerçekleştirildi. Kalibrasyon grafikleri, beş farklı konsantrasyonda (10-100 µg/mL) standart α-tokoferol örneklerinin absorbanslarına karşılık gelen konsantrasyonların çizilmesiyle oluşturuldu. Bulgular: Farmasötik yumuşak kapsüldeki α-tokoferol miktarı %101,572 (203,145 IU/kapsül) olarak hesaplandı (Evicap yumuşak kapsül etiket içeriği: 200 IU/kapsül). Sonuç: Bu çalışmada geliştirilen spektrofotometrik yöntemin doğru, duyarlı, hassas, tekrarlanabilir olduğu ve yumuşak kapsül ve diğer farmasötik preparatlara kolayca uygulanabileceği ileri sürülmektedir.

Keywords

• Spektrofotometri
• farmasötik yumuşak kapsül
• α-tokoferol

Quantitative Determination of α-Tocopherol in Pharmaceutical Soft Capsule by Spectrophotometry

Abstract

Objective: Vitamin E is an essential micronutrient for maintaining a healthy status and preventing disease. The purpose of this study was to develop and validate a simple, sensitive and easily applicable spectrophotometric method for determination of α-tocopherol in pharmaceutical preparations. Material and Method: The quantitative determination of the α-tocopherol in pharmaceutical prepation was carried out using the maximum absorbance value measured at 290 nm. Calibration graphs were constructed by plotting the absorbance against the corresponding concentration of standart α-tocopherol samples at five different concentrations (10-100 µg/mL). Results: The amount of α-tocopherol in the pharmaceutical soft capsule was calculated as 101.572% (203.145 IU/capsule) (Evicap soft capsule labelled content: 200 IU/capsule). Conclusion: It suggested that the developed spectrophotometric method in this study is accurate, sensitive, precise, reproducible and easily applied to soft capsules and the other pharmaceutical preparations.

Keywords

• Spectrophotometry
• pharmaceutical soft capsule
• α-tocopherol

References

1. 1. Litwack G. Vitamin E: Vitamins and Hormones. Vol. 76, Elsevier Inc. Elsevier; 2007. 2-60,531 p.
2. 2. Rucker RB, Suttie JW, McCormick DB. Handbook of Vitamins, 3rd Edition (Clinical Nutrition in Health and Disease, No. 3). Taylor&Francis; 2001. 153-175 p.
3. 3. Weber, Peter; Birringer, Marc; Blumberg, B. Jeffery; Eggersdorfer, Manfred; Frank J. Vitamin E in Human Health. Vitamin E in Human Health. Springer; 2019. [CrossRef]
4. 4. Praça FG, Viegas JSR, Peh HY, Garbin TN, Medina WSG, Bentley MVLB. Microemulsion co-delivering vitamin A and vitamin E as a new platform for topical treatment of acute skin inflammation. Mater Sci Eng C 2020; 110. [CrossRef]
5. 5. Muripiti V, Mujahid TY, Boddeda VHV, Tiwari S, Marepally SK, Patri SV, et al. Structure-activity relationship of serotonin derived tocopherol lipids. Int J Pharm 2019; 554: 134-48. [CrossRef]
6. 6. Palan PR, Woodall AL, Anderson PS, Mikhail MS. α-Tocopherol and α-tocopheryl quinone levels in cervical intraepithelial neoplasia and cervical cancer. Am J Obstet Gynecol 2004; 190(5): 1407-10. [CrossRef]
7. 7. Sato R, Helzlsouer KJ, Alberg AJ, Hoffman SC, Norkus EP, Comstock GW. Prospective study of carotenoids, tocopherols, and retinoid concentrations and the risk of breast cancer. Cancer Epidemiol Biomarkers Prev 2002; 11(5): 451-7.
8. 8. Fuller CJ, Jialal I. Effects of antioxidants and fatty acids on low-density-lipoprotein oxidation. Am J Clin Nutr 1994; 60(6): 1010-1013. [CrossRef]

9. 9. Mancini M, Parfitt VJ, Rubba P. Antioxidants in the Mediterranean diet. Can J Cardiol 1995; 11: 105-9.
10. 10. Saldanha RL, Cepeda EE, Poland RL. The effect of vitamin E prophylaxis on the incidence and severity of bronchopulmonary dysplasia. J Pediatr 1982; 101(1): 89-93. [CrossRef]
11. 11. Phelps DL, Rosenbaum AL, Isenberg SJ, Leake RD, Dorey FJ. Tocopherol efficacy and safety for preventing retinopathy of prematurity: a randomized, controlled, double-masked trial. Pediatrics 1987; 79(4): 489-500.
12. 12. Lu R, Groer C, Kleindl PA, Moulder KR, Huang A, Hunt JR, et al. Formulation and preclinical evaluation of a toll-like receptor 7/8 agonist as an anti-tumoral immunomodulator. J Control Release 2019; 306: 165-76. [CrossRef]
13. 13. Shanmugapriya K, Kim H, Kang HW. In vitro antitumor potential of astaxanthin nanoemulsion against cancer cells via mitochondrial mediated apoptosis. Int J Pharm 2019; 560:334-46. [CrossRef]
14. 14. Zhang X, Liang N, Gong X, Kawashima Y, Cui F, Sun S. Tumor-targeting micelles based on folic acid and α-tocopherol succinate conjugated hyaluronic acid for paclitaxel delivery. Colloids Surfaces B Biointerfaces 2019; 177: 11-8. [CrossRef]
15. 15. Zhang L, Zhang T, Chang M, Lu M, Liu R, Jin Q, et al. Effects of interaction between α-tocopherol, oryzanol, and phytosterol on the antiradical activity against DPPH radical. LWT 2019; 112: 108206. [CrossRef]
16. 16. Teixeira MC, Severino P, Andreani T, Boonme P, Santini A, Silva AM, et al. D-α-tocopherol nanoemulsions: Size properties, rheological behavior, surface tension, osmolarity and cytotoxicity. Saudi Pharm J 2017; 25(2): 231-5. [CrossRef]
17. 17. Scott ML. Vitamin E in Health and Disease of Poultry. Vol. 20, Vitamins and Hormones. Dekker; 1962. 621-632 p. [CrossRef]
18. 18. San Andrés MP, Otero J, Vera S. High performance liquid chromatography method for the simultaneous determination of α-, γ- And δ-tocopherol in vegetable oils in presence of hexadecyltrimethylammonium bromide/n-propanol in mobile phase. Food Chem 2011; 126(3): 1470-4. [CrossRef]
19. 19. Aly N, Krishnaiah YSR, Zaghloul AA, Ibrahim K. Analysis of vitamin e in commercial cosmetic preparations by HPLC. J Cosmet Sci 2010; 61(5): 353-65.
20. 20. Demirkaya F, Kadioglu Y. Simple GC-FID method development and validation for determination of α-tocopherol (vitamin E) in human plasma. J Biochem Biophys Methods 2007; 70(3): 363-8. [CrossRef]
21. 21. Semeraro A, Altieri I, Patriarca M, Menditto A. Evaluation of uncertainty of measurement from method validation data: An application to the simultaneous determination of retinol and α-tocopherol in human serum by HPLC. J Chromatogr B Anal Technol Biomed Life Sci 2009; 877(11-12): 1209-15. [CrossRef]
22. 22. Özkırımlı S, ÇAPAN G, Demiroğlu C. Determination of α-Tocopherol Concentration in Plasma Using High Performance Liquid Chromotography. Acta Pharm Turc 1988; 30: 161-5.
23. 23. Aoun E, Rima J, Chidiac G, Hanna K. High-performance liquid chromatographic and spectrofluorometric determination of α-tocopherol in a natural plant: Ferula hermonis (Zalooh root). J Food Compos Anal 2005; 18(7): 607-15. [CrossRef]
24. 24. Yilmaz B, Öztürk M, Kadioğlu Y. Comparison of two derivative spectrophotometric methods for the determination of α-tocopherol in pharmaceutical preparations. Farmaco 2004; 59(9): 723-7. [CrossRef]
25. 25. Poudel A, Gachumi G, Badea I, Bashi ZD, El-Aneed A. The simultaneous quantification of phytosterols and tocopherols in liposomal formulations using validated atmospheric pressure chemical ionization- liquid chromatography -tandem mass spectrometry. J Pharm Biomed Anal 2020;183:113104. [CrossRef]
26. 26. Guidance for Industry Q2B Validation of Analytical Procedures: Methodology. 1996
27. 27. Zhang H, Quan L, Pei P, Lin Y, Feng C, Guan H, et al. Simultaneous determination of Vitamin A, 25-hydroxyl vitamin D3 α-tocopherol in small biological fluids by liquid chromatography-tandem mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci 2018; 1079: 1-8. [CrossRef]
28. 28. Jaiswal PV, Ijeri VS, Srivastava AK. Voltammetric behavior of α-tocopherol and its determination using surfactant + ethanol + water and surfactant + acetonitrile + water mixed solvent systems. Anal Chim Acta 2001; 441(2): 201-6. [CrossRef]