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Forced stability studies and estimation of encapsulated ellagic acid in nano-formulations using UV-spectroscopy

  • Suraj Kumar

    Suraj Kumar received his M.S. (Pharm.) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India. His area of research is in the field of novel drug delivery systems, particularly drug targeting of colon cancer.

    , Yogesh Khairnar

    Yogesh Khairnar completed his M.S. (Pharm.) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India. His area of research is enhancement of oral bioavailability of drugs.

    , Arka Karmakar

    Arka Karmakar is pursuing his Ph.D. in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India. His area of research is novel drug delivery systems.

    and Lalit Kumar

    Lalit Kumar received his Ph.D. in Pharmaceutical Sciences from Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India in 2016. He holds 3 Indian patents, has filed 7 patents, published 2 books, more than 35 book chapters and about 130 articles in peer-reviewed journals. He has about 15 years of teaching and research experience. His work includes novel drug delivery systems (especially nanoformulations), analytical method development and QbD. He has successfully completed more than ten research projects funded by AICTE, New Delhi, State of Karnataka VGST, Bengaluru, ICMR, New Delhi, SERB, New Delhi. He is currently working as Assistant Professor in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.

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Published/Copyright: November 5, 2024
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Abstract

There is a growing interest in dietary materials to explore their therapeutic activities. Ellagic acid is considered as a dietary supplement and is naturally present in fruits and other foods. It has anticancer, antimalarial, antiviral, antioxidant, and anti-inflammatory activities. These activities can be enhanced with nanoformulations, which can increase its oral bioavailability. However, there is a need for an economical, simple, sensitive, and robust analytical method for the estimation of entrapped ellagic acid in the nanoformulations. Therefore, the present study presents the development and validation of a UV–visible spectroscopy method for the estimation of EA in nanoformulations. The phosphate buffer (pH 7.2) and the detection wavelength of 253.5 nm were used for the method development, and its validation was performed according to the ICH Q2A (R1) guidelines. The coefficient of determination value of the developed method was found to be 0.9988 in the concentration range of 1 μg mL−1 to 6 μg mL−1. The method was found to be linear, precise, sensitive, and robust. This method can be used for the estimation of EA in nanoformulations, bulk dosage forms, and other pharmaceutical formulations.


Corresponding authors: Lalit Kumar, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur 844 102, Vaishali, Bihar, India, E-mail:

About the authors

Suraj Kumar

Suraj Kumar received his M.S. (Pharm.) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India. His area of research is in the field of novel drug delivery systems, particularly drug targeting of colon cancer.

Yogesh Khairnar

Yogesh Khairnar completed his M.S. (Pharm.) in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India. His area of research is enhancement of oral bioavailability of drugs.

Arka Karmakar

Arka Karmakar is pursuing his Ph.D. in Pharmaceutics from the National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India. His area of research is novel drug delivery systems.

Lalit Kumar

Lalit Kumar received his Ph.D. in Pharmaceutical Sciences from Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India in 2016. He holds 3 Indian patents, has filed 7 patents, published 2 books, more than 35 book chapters and about 130 articles in peer-reviewed journals. He has about 15 years of teaching and research experience. His work includes novel drug delivery systems (especially nanoformulations), analytical method development and QbD. He has successfully completed more than ten research projects funded by AICTE, New Delhi, State of Karnataka VGST, Bengaluru, ICMR, New Delhi, SERB, New Delhi. He is currently working as Assistant Professor in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.

Acknowledgments

The authors would like to acknowledge the National Institute of Pharmaceutical Education and Research, Hajipur, Vaishali, Bihar, India, for providing the infrastructural facilities to complete this research.

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interests: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: Not applicable.

References

1. Sonule, B.; Mehetre, N.; Kumar, L. Determination of Resveratrol in Nanoformulations Using UV-Spectroscopy: Forced Degradation and Drug Entrapment. Tenside Surfact. Det. 2024, 61 (4), 358–365. https://doi.org/10.1515/tsd-2024-2595.Search in Google Scholar

2. Tsao, R. Chemistry and Biochemistry of Dietary Polyphenols. Nutrients 2010, 2 (12), 1231–1246. https://doi.org/10.3390/nu2121231.Search in Google Scholar PubMed PubMed Central

3. Çeribaş, A. O.; Sakin, F.; Türk, G.; Sönmez, M.; Ateşşahin, A. Impact of Ellagic Acid on Adriamycin-Induced Testicular Histopathological Lesions, Apoptosis, Lipid Peroxidation, and Sperm Damages. Exp. Toxicol. Pathol. 2012, 64 (7-8), 717–724. https://doi.org/10.1016/j.etp.2011.01.006.Search in Google Scholar PubMed

4. Navarro-Hortal, M. D.; Varela-Lόpez, A.; Romero-Márquez, J. M.; Rivas-Garcίa, L.; Speranza, L.; Battino, M.; Quiles, J. L. Role of Flavonoids against Adriamycin Toxicity. Food Chem. Toxicol. 2020, 146. https://doi.org/10.1016/j.fct.2020.111820.Search in Google Scholar PubMed

5. Umesalma, S.; Sudhandiran, G. Differential Inhibitory Effects of the Polyphenol Ellagic Acid on Inflammatory Mediators NF-KB, INOS, COX-2, TNF-α, and IL-6 in 1,2-Dimethylbutane-Induced Rat Colon Carcinogenesis. Basic Clin. Pharmacol. Toxicol. 2010, 107 (2), 650–655. https://doi.org/10.1111/j.1742-7843.2010.00565.x.Search in Google Scholar PubMed

6. Chen, G. H.; Lin, Y. L.; Hsu, W. L.; Hsieh, S. K.; Tzen, J. T. C. Significant Elevation of Antiviral Activity of Strictinin from Pu’er Tea after Thermal Degradation of Ellagic Acid and Gallic Acid. J. Food Drug Analy. 2015, 23 (1), 116–123. https://doi.org/10.1016/j.jfda.2014.07.007.Search in Google Scholar PubMed PubMed Central

7. Wang, D.; Chen, Q.; Liu, B.; Li, Y.; Tan, Y.; Yang, B. Ellagic Acid Inhibits Proliferation and Induces Apoptosis in Human Glioblastoma Cells. Acta Cir. Bras. 2016, 31 (2), 143–149. https://doi.org/10.1590/S0102-865020160020000010.Search in Google Scholar PubMed

8. Derosa, G.; Maffioli, P.; Sahebkar, A. Ellagic Acid and its Role in Chronic Diseases. In Anti-Inflammatory Nutraceuticals Chronic Diseases. Adv Exp Med Biol; Gupta, S.; Prasad, S.; Aggarwal, B., Eds.; Springer: Cham, Vol. 928, 2016; pp. 473–479.10.1007/978-3-319-41334-1_20Search in Google Scholar PubMed

9. Soh, P. N.; Witkowski, B.; Olagnier, D.; Nicolau, M. L.; Garcia-Alvarez, M. C.; Berry, A.; Benoit-Vical, F. In Vitro And In Vivo Properties of Ellagic Acid in Malaria Treatment. Antimicrob. Agent. Chemother. 2009, 53 (3), 1100–1106. https://doi.org/10.1128/AAC.01175-08.Search in Google Scholar PubMed PubMed Central

10. Sepúlveda, L.; Ascacio, A.; Rodrίguez-Herrera, R.; Aguilera-Carbό, A.; Aguilar, C. N. Ellagic Acid: Biological Properties and Biotechnological Development of Production Processes. Aftr. J. Biotechnol. 2011, 10 (22), 4518–1523. https://doi.org/10.5897/AJB10.2201.Search in Google Scholar

11. Park, S. W.; Kwon, M. J.; Yoo, J. Y.; Choi, H. J.; Ahn, Y. J. Antiviral Activity and Possible Mode of Action of Ellagic Acid Identified in Lagerstroemia Speciosa Leaves towards Human Rhinoviruses. BMC Compl. Altern. Med. 2014, 14 (1), 171. https://doi.org/10.1186/1472-6882-14-171.Search in Google Scholar PubMed PubMed Central

12. Meyer, A. S.; Heinonen, M.; Frankel, E. N. Antioxidant Interactions of Catechin, Cyanidin, Caffeic Acid, Quercetin, and Ellagic Acid on Human LDL Oxidation. Food Chem. 1998, 61 (1-2), 71–75. https://doi.org/10.1016/S0308-8146(97)00100-3.Search in Google Scholar

13. Priyadarsini, K. I.; Khopde, S. M.; Kumar, S. S.; Mohan, H. Free Radical Studies of Ellagic Acid, a Natural Phenolic Antioxidant. J. Agric. Food Chem. 2002, 50 (7), 2200–2206. https://doi.org/10.1021/jf011275g.Search in Google Scholar PubMed

14. Seeram, N. P.; Adams, L. S.; Henning, S. M.; Niu, Y.; Zhang, Y.; Nair, M. G.; Heber, D. In Vitro Antiproliferative, Apoptotic, and Antioxidant Activities of Punicalagin, Ellagic Acid and a Total Pomegranate Tannin Extract Are Enhanced in Combination with Other Polyphenols as Found in Pomegranate Juice. J. Nutr. Biochem. 2005, 16 (6), 360–367. https://doi.org/10.1016/j.jnutbio.2005.01.006.Search in Google Scholar PubMed

15. Corbett, S.; Daniel, J.; Drayton, R.; Field, M.; Steinhardt, R.; Garrett, N. Evaluation of the Anti-inflammatory Effects of Ellagic Acid. J. PeriAnesthesia Nurs. 2010, 25 (4), 214–220. https://doi.org/10.1016/j.jopan.2010.05.011.Search in Google Scholar PubMed

16. Bala, I.; Bhardwaj, V.; Hariharan, S.; Ravi Kumar, M. N. V. Analytical Methods for Assay of Ellagic Acid and its Solubility Studies. J. Pharma. Biomed. Anal. 2006, 40 (1), 206–210. https://doi.org/10.1016/j.jpba.2005.07.006.Search in Google Scholar PubMed

17. Vasudev, S. S.; Ahmed, F. J.; Khar, R. K.; Bhatnagar, A.; Kamal, Y. T.; Talegaonkar, S.; Iqbal, Z. Validated HPLC Method for the Simultaneous Determination of Taxol and Ellagic Acid in a Punica Granatum Fruit Extract Containing Combination Formulation. Pharmazie 2012, 67, 834–838. https://doi.org/10.1691/ph.2012.1156.Search in Google Scholar

18. Assunção, P. I. D.; da Conceição, E. C.; Borges, L. L.; de Paula, J. A. M. Development and Validation of a HPLC-UV Method for the Evaluation of Ellagic Acid in Liquid Extracts of Eugenia Uniflora L. (Myrtaceae) Leaves and its Ultrasound-Assisted Extraction Optimization. Evidence-Based Complementary Altern. Med 2017, 2017. https://doi.org/10.1155/2017/1501038.Search in Google Scholar PubMed PubMed Central

19. Syed, Y.; Khan, M. Chromatographic Profiling of Ellagic Acid in Woodfordia Fruticosa Flowers and Their Gastroprotective Potential in Ethanol-Induced Ulcers in Rats. Pharmacogn. Res. 2016, 8 (Suppl 1), S1–S11. https://doi.org/10.4103/0974-8490.178649.Search in Google Scholar PubMed PubMed Central

20. Owczarek, A.; Gudej, J. Investigation into Biologically Active Constituents of Geum Rivale L. Acta Pol. Pharm. Drug Res. 2013, 70 (11), 111–114.Search in Google Scholar

21. Kadam, P. V.; Yadav, K. N.; Bhingare, C. L.; Patil, M. J. Development and Validation of a HPLC Analytical Method for Determination of Ellagic Acid in Epilobium Angustifolium Extract. Int. J. Pharm. Sci. Res. 2019, 10 (3), 1300–1306. https://doi.org/10.13040/IJPSR.0975-8232.10(3).1300-06.Search in Google Scholar

22. Amakura, Y.; Okada, M.; Tsuji, S.; Tonogai, Y. High-performance Liquid Chromatographic Determination with Photodiode Array Detection of Ellagic Acid in Fresh and Processed Fruits. J. Chromatogr. A. 2000, 896, 87–93. https://doi.org/10.1016/S0021-9673(00)00414-3.Search in Google Scholar

23. Aguilera-Carbo, A. F.; Augur, C.; Prado-Barragan, L. A.; Aguilar, C. N.; Favela-Torres, E. Extraction and Analysis of Ellagic Acid from Novel Complex Sources. Chem. Pap. 2008, 62, 440–444. https://doi.org/10.2478/s11696-008-0042-y.Search in Google Scholar

24. Sandhu, A. K.; Gu, L. Antioxidant Capacity, Phenolic Content, and Profiling of Phenolic Compounds in the Seeds, Skin, and Pulp of Vitis Rotundifolia (Muscadine Grapes) as Determined by HPLC-DAD-ESI-MSn. J. Agric. Food Chem. 2010, 58 (8), 4681–4692. https://doi.org/10.1021/jf904211q.Search in Google Scholar PubMed

25. Kumar Kammala, A.; Kumar Ramasamy, M.; Aruna, A. G. D.; Kaliappan, I. Development and Validation of a RP-HPLC Method for the Simultaneous Determination of Mangiferin, Ellagic Acid, and Hydroxycitric Acid in Polyherbal Formulation. Pharmacogn. J. 2014, 6 (3), 23–28. https://doi.org/10.5530/pj.2014.3.4.Search in Google Scholar

26. Riffault, L.; Destandau, E.; Pasquier, L.; André, P.; Elfakir, C. Phytochemical analysis of rosa hybrida cv. “Jardin de Granville” by HPTLC, HPLC-DAD, and HPLC-ESI-HRMS: Polyphenolic fingerprints of six plant organs. Phytochemistry 2014, 99, 127–134. https://doi.org/10.1016/j.phytochem.2013.12.015.Search in Google Scholar PubMed

27. Dhanani, T.; Shah, S.; Kumar, S. A Validated High-Performance Liquid Chromatography Method for Determination of Tannin-Related Marker Constituents Gallic Acid, Corilagin, Chebulagic Acid, Ellagic Acid, and Chebulinic Acid in Four terminalia Species from India. J. Chromatogr. Sci. 2015, 53 (4), 625–632. https://doi.org/10.1093/chromsci/bmu096.Search in Google Scholar PubMed

28. Chernonosov, A. A.; Karpova, E. A.; Lyakh, E. M. Identification of Phenolic Compounds in Myricaria Bracteata Leaves by High-Performance Liquid Chromatography with a Diode Array Detector and Liquid Chromatography with Tandem Mass Spectroscopy. Rev. Bras. Farmacogn. 2017, 27 (5), 576–579. https://doi.org/10.1016/j.bjp.2017.07.001.Search in Google Scholar

29. Silva, L. S.; de Oliveira, M. G.; Martins, C. F.; Borges, L. L.; Fiuza, T. S.; da Conceição, E. C.; de Paula, J. R. Validation HPLC-DAD Method for Quantification of Gallic and Ellagic Acid from Eugenia Punicifolia Leaves, Extracts, and Fractions. J. Braz. Chem. Soc. 2023, 34 (3), 401–413. https://doi.org/10.21577/0103-5053.20220117.Search in Google Scholar

30. Lee, J. H.; Johnson, J. V.; Talcott, S. T. Identification of Ellagic Acid Conjugates and Other Polyphenolics in Muscadine Grapes by HPLC-ESI-MS. J. Agric. Food Chem. 2005, 53 (15), 6003–6010. https://doi.org/10.1021/jf050468r.Search in Google Scholar PubMed

31. Kumar, S.; Singh, A.; Kumar, B. Identification and Characterization of Phenolics and Terpenoids from Ethanolic Extracts of Phyllanthus Species by HPLC-ESI-QTOF-MS/MS. J. Pharm. Anal. 2017, 7 (4), 214–222. https://doi.org/10.1016/j.jpha.2017.01.005.Search in Google Scholar PubMed PubMed Central

32. Aaby, K.; Ekeberg, D.; Skrede, G. Characterization of Phenolic Compound in Strawberry (Fragaria × Ananassa) Fruits by Different HPLC Detectors and Contribution of Individual Compounds to Total Antioxidant Capacity. J. Agric. Food Chem. 2007, 55, 4395–4406. https://doi.org/10.1021/jf0702592.Search in Google Scholar PubMed

33. Patel, V. R.; Patel, R. K. HPTLC Method Development and Validation for Quantification of Markers of Dhatrinisha Churna. Pharmacogn. J. 2012, 4 (29), 26–29. https://doi.org/10.5530/pj.2012.29.4.Search in Google Scholar

34. Tiwari, P.; Patel, R. K. Quantification of Gallic Acid and Ellagic Acid in Arjunarishta by Validated HPTLC Densitometry. Int. J. Pharm. Sci. Res. 2012, 3(7), 225–2223. https://doi.org/10.13040/IJPSR.0975-8232.Search in Google Scholar

35. Patel, V.; Patel, R. Simultaneous Analysis and Quantification of Markers of Manjisthadi Churna Using High-Performance Thin Layer Chromatography. Indian J. Pharm. Sci. 2013, 75 (1), 106–109. https://doi.org/10.4103/0250-474X.113541.Search in Google Scholar PubMed PubMed Central

36. Yan, L.; Yin, P.; Ma, C.; Liu, Y. Method Development and Validation for Pharmacokinetic and Tissue Distributions of Ellagic Acid Using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS). Molecules 2014, 19, 18923–18935. https://doi.org/10.3390/molecules191118923.Search in Google Scholar PubMed PubMed Central

37. Shen, Y.; Liu, S.; Wang, J.; Li, D.; He, Y. Determination of Ellagic Acid by Fluorescence Quenching Method with Glutathione Capped CdTe Quantum Dots as the Probe. Anal. Method 2013, 5, 3228–3234. https://doi.org/10.1039/c3ay40365c.Search in Google Scholar

38. ICH Harmonized Tripartite Guidelines Validation of Analytical Procedures: Text and Methodology Q2(R1), 2005.Search in Google Scholar

39. Kola Srinivas, N. S.; Verma, R.; Kulyadi, G. P.; Kumar, L. A Quality by Design Approach on Polymeric Nanocarrier Delivery of Gefitinib: Formulation, In Vitro, and In Vivo Characterization. Int. J. Nanomed. 2017, 12, 15–28. https://doi.org/10.2147/IJN.S122729.Search in Google Scholar PubMed PubMed Central

40. Hasegawa, M.; Terauchi, M.; Kikuchi, Y.; Nakao, A.; Okubo, J.; Yoshinaga, T.; Hiratsuka, H.; Kobayashi, M.; Hoshi, T. Deprotonation Processes of Ellagic Acid in Solution and Solid States. Monatshefte für Chem./Chem. Monthly 2003, 134, 811–821. https://doi.org/10.1007/s00706-002-0552-1.Search in Google Scholar

41. Panichayupakaranant, P.; Itsuriya, A.; Sirikatitham, A. Preparation Method and Stability of Ellagic Acid-Rich Pomegranate Fruit Peel Extract. Pharma. Biol. 2010, 48 (2), 201–205. https://doi.org/10.3109/13880200903078503.Search in Google Scholar PubMed

42. Agrawal, O. D.; Kulkarni, Y. A. Mini-review of Analytical Methods Used in Quantification of Ellagic Acid. Rev. Anal. Chem. 2020, 39 (1), 31–44. https://doi.org/10.1515/revac-2020-0113.Search in Google Scholar

Received: 2024-07-19
Accepted: 2024-10-07
Published Online: 2024-11-05
Published in Print: 2025-01-29

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