Author(s):
Ajay Kumar Meena, Vikas Ojha, Vijay Kumar, Arjun Singh, Preeti Sharma, N. Srikanth, Rabinarayan Acharya
Email(s):
ajay.meena@gov.in , ajaysheera@gmail.com
DOI:
10.52711/0974-360X.2025.00118 
Address:
Ajay Kumar Meena*1, Vikas Ojha1, Vijay Kumar2, Arjun Singh3, Preeti Sharma3, N. Srikanth3, Rabinarayan Acharya3
1Regional Ayurveda Research Institute, Aamkho, Gwalior – 474009.
2Central Ayurveda Research Institute, Jhansi – 284003.
3Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India, New Delhi – 110058.
*Corresponding Author
Published In:
Volume - 18,
Issue - 2,
Year - 2025
ABSTRACT:
This research investigates the Ayurvedic Gel Formulation (AGF), an Ayurvedic product, utilizing various analytical techniques to assess its quality, safety, and stability. The AGF underwent stringent packaging in containers, following ICH guidelines Q1A (R2), to undergo extended shelf-life studies at 30°C ± 2°C and 60% RH ± 5% RH. Continuous evaluations, including physico-chemical and marker-based assessments, were conducted, with a control sample. The shelf-life dynamics were scrutinized through withdrawals at zero days and at 3-month intervals. This research article presents a thorough investigation into the HPTLC fingerprint profiling of Mimosa pudica plant and AGF, employing a solvent system of n-hexane: Ethyl acetate: Formic acid (6:4:0.1 v/v) with Linoleic acid as the reference standard. The study utilized UV observation at 254 nm and 366 nm, iodine vapors derivatization, and anisaldehyde-sulphuric acid reagent for detection, yielding comprehensive HPTLC fingerprint profiles. Safety parameters, encompassing microbial load, specific pathogens, and aflatoxin analysis, along with Total Phenolic Content (TPC) (0.3087%w/w) and Total Flavonoid Content (TFC) (0.1828%w/w), were systematically examined. The quantified results disclosed linoleic acid content in AGF (0.0182%) and Mimosa pudica (0.04119%). Palmitic acid analysis in AGF (0.0351%) and Coconut Oil (0.0119%) further validated the formulation. Safety evaluations demonstrated compliance with permissible limits for heavy metals, while microbial analysis highlighted a moderate aerobic count and low fungal count, ensuring high hygiene standards. Aflatoxin levels below quantifiable limits and pesticide residues within detectable limits emphasized adherence to safety standards. Thermal analysis confirmed the stability of AGF, providing a comprehensive understanding of its safety, quality, and compositional attributes in Ayurvedic formulations.
Cite this article:
Ajay Kumar Meena, Vikas Ojha, Vijay Kumar, Arjun Singh, Preeti Sharma, N. Srikanth, Rabinarayan Acharya. A Holistic Approach to Ayurvedic Gel Stability: Qualitative and quantitative estimation of Bio Markers using HPTLC, HPLC and GC. Research Journal of Pharmacy and Technology.2025;18(2):797-8. doi: 10.52711/0974-360X.2025.00118
Cite(Electronic):
Ajay Kumar Meena, Vikas Ojha, Vijay Kumar, Arjun Singh, Preeti Sharma, N. Srikanth, Rabinarayan Acharya. A Holistic Approach to Ayurvedic Gel Stability: Qualitative and quantitative estimation of Bio Markers using HPTLC, HPLC and GC. Research Journal of Pharmacy and Technology.2025;18(2):797-8. doi: 10.52711/0974-360X.2025.00118 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-2-50
5. REFERENCES:
1. Anonymous. Ayurvedic Pharmacopoeia of India (API). Part I, Vol.1, 1st Ed. Govt. of India, Ministry of Health and Family Welfare, Dept. of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, New Delhi, 2001.
2. Sastri P. Sharangadhara Samhita written by Acharya sharangadhara with commentary. Published by Choukhambha Orientalia, Varanasi, 4th edition, 2002: 13.
3. K Bankoti, MS Rana, MK Bharadwaj. Accelerated stability study of herbal capsules. IOSR Journal of Pharmacy. 2012; 2(5): 1-6.
4. Cannors KA, Amidon GL and Kennon L. Chemical Stability of Pharmaceuticals - A handbook of Pharmacists. John Wiley and Sons, New York, 1979.
5. Mitkari B. V., Korde S. A., Mahadik K. R., Kokare C. R. Formulation and evaluation of topical liposomal gel for fluconazole. Indian Journal of Pharmaceutical Education and Research. 2010; 44(4): 324–333.
6. Glavas-Dodov M., Fredro-Kumbaradzi E., Goracinova K., Calis S., Simonoska M., Hincal A. A. 5-Fluorouracil in topical liposome gels for anticancer treatment-formulation and evaluation. Acta Pharmaceutica. 2003; 53(4): 241–250.
7. Kaur L. P., Guleri T. K. Topical gel: recent approach for novel drug delivery. Asian Journal of Biomedical and Pharmaceutical Sciences. 2013; 3(17): 1–5.
8. Whitehouse M. W. Anti-inflammatory glucocorticoid drugs: reflections after 60 years. Inflammopharmacology. 2011; 19(1): 1–19.
9. Rupal J., Kaushal J., Setty C., Mallikarjuna S. C., Dipti P. Preparation and evaluation of topical gel of valdecoxib. International Journal of Pharmaceutical Sciences and Drug Research. 2010; 2(1): 51–54.
10. Bhasha S. A., Khalid S. A., Duraivel S., Bhowmik D., Kumar K. S. Recent trends in usage of polymers in the formulation of dermatological gels. Indian Journal Research Pharmacy Biotechnology. 2013; 1(2): 161–168.
11. Sharma S., Pawar S., Jain U. K. Development and evaluation of topical gel of curcumin from different combination of polymers formulation and evaluation of herbal gel. International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(4): 452–456.
12. Gisby J., Bryant J. Efficacy of a new cream formulation of mupirocin: comparison with oral and topical agents in experimental skin infections. Antimicrobial Agents and Chemotherapy. 2000; 44(2): 255–260.
13. Verma A., Singh S., Kaur R., Kumar A., Jain U. K. Formulation, optimization and evaluation of clobetasol propionate gel. International Journal of Pharmacy and Pharmaceutical Sciences. 2013; 5(4): 666–674.
14. Karadzovska D., Brooks J. D., Monteiro-Riviere N. A., Riviere J. E. Predicting skin permeability from complex vehicles. Advanced Drug Delivery Reviews. 2013; 65(2): 265–277.
15. Cevc G., Blume G. New, highly efficient formulation of diclofenac for the topical, transdermal administration in ultradeformable drug carriers, Transfersomes. Biochimica et Biophysica Acta (BBA)—Biomembranes. 2001; 1514(2): 191–205.
16. Y. Jamuna Devi; Antifertility Activity of Different Extracts of Mimosa Pudica Linn Leaves in Female Rats; ISSN (Online): 2319-7064; 6(3), March 2017: 826-830.
17. Y. N. Gandhiraja, S. Sriram,* V. Meenaa, J. Kavitha Srilakshmi, C. Sasikumar and R.Rajeswari; Phytochemical Screening and Antimicrobial Activity of the Plant Extracts of Mimosa pudica L. Against Selected Microbes.; Ethnobotanical Leaflets. 2009, 13:618-24.
18. I Ibrahim D, I Muhhmmad, A.I. Kanoma, Kasimu Shehu ; “Antifungal screening of Mimosa Pudica Plant Extracts against Phytopathogenic Fungi.”; Open Science Journal of Bioscience and Bioengeeniering. 2014; 1(1); 1- 12.
19. Qiao C, Han Q, Song J, Mo S, Kong L, et al. Chemical fingerprint quantitative analysis of Fructus Psoraleae by high-performance liquid chromatography. Journal of Separation Science 2007; 30: 813-818.
20. Lu H, Liang Y, Chen S, Identification and quality assessment of Houttuynia cordatainjection using GC-MS fingerprint: a standardization approach. Journal of Ethnopharmacology 2006; 105: 436-440.
21. Li K, Wang S, Fingerprint chromatogram analysis of extracts from the leaves of Tripterygium wilfordi Hook. F. by high performance liquid chromatography. Journal of Separation Science 2005; 28: 653-657.
22. The HPLC instrument (Agilent Technologies 1260 series) Manuals.
23. Meena, A. K., Ilavarasan, R., Perumal, A., Singh, R., Ojha, V., Srikanth, N., and Dhiman, K. S. (2022). Evaluation for substitution of stem bark with small branches of Cassia fistula Linn for traditional medicinal uses: A comparative chemical profiling studies by HPLC, LC-MS, GC-MS. Heliyon, 8(8), e10251.
24. Meena, A. K., Ilavarasan, R., Ojha, V., Perumal, A., Singh, R., Srikanth, N., and Dhiman, K. S. (2023). Using Small Branches of Bombax ceiba Instead of Stem Bark for a Conservative Sourcing Approach: Comparative Studies of Chemical Profiling by LC-MS, GC-MS, and HPLC. Chemistry Select, 8(5), 3623-3628.
25. Eiceman, G. A., Gardea-Torresdey, J., Overton, E., Carney, K., and Dorman, F. (2002). Gas Chromatography. Analytical Chemistry, 74(12), 2771–2780.
26. Manousi, N., and Samanidou, V. F. (2019). Applications of Gas Chromatography for the Analysis of Tricyclic Antidepressants in Biological Matrices. Separations, 6(2), 24.
27. Charde, V., Jagtap, C., Kumar, V., Kushwaha, V., Grewal, J., Mishra, S. K., Shakya, S. K., Soni, H., Singh, G., Babu, G., Singh, A., Singh, R., Khanduri, S., Sharma, B. S., and Srikanth, N. (2022). Comparative shelf-life study of Raw Guggulu (Commiphora wightii oleo-gum resin) and Shodhita Guggulu (cow urine processed C. wightii oleo-gum resin). Journal of Drug Research in Ayurvedic Sciences, 7(1), 47-54.
28. Anonymous. ICH Harmonised Tripartite Guideline. Stability Testing of New Drug Substances and Products–Q1A (R2). 2003. https://www.ich.org/page/quality-guidelines.
29. Kumar V, Singh S, Singh S, Datta S, Dhanjal DS, Singh J. Methods and techniques for the chemical profiling and quality control of natural products and natural product-derived drugs. In: Singh J, Meshram V, Gupta M, editors. Bioactive Natural Products in Drug Discovery. Singapore: Springer; 2020. p. 585–98.
30. Muller P, Basedow T. Aflatoxin contamination of pods of Indian Cassia senna L. (Caesalpinaceae) before harvest, during drying and in storage: Reasons and possible methods of reduction. J Stored Prod Res 2007; 43: 323–9.
31. Anonymous (2003). Ayurvedic Formulary of India. Part I-III. Ministry of Health and Family Welfare, Government of India, New Delhi, India.
32. Anonymous (2008). Department of AYUSH, Ministry of Health and Family Welfare, Government of India. The Ayurvedic Pharmacopoeia of India. 1st ed. Part I vol. VI. New Delhi: Department of AYUSH, Ministry of Health and Family Welfare, Government of India. 233-291.
33. Muller, P., Basedow, T. (2007). Aflatoxin contamination of pods of Indian Cassia senna L. 988 (Caesalpinaceae) before harvest, during drying and in storage: Reasons and possible 989 methods of reduction. J. Stored Prod. Res., 43, 323-329.
34. Beneta, A., Pavlović, D.M., Periša, I.C., Petrović, M. (2018). Multiresidue GC-MS/MS 815 pesticide analysis for evaluation of tea and herbal infusion safety. Int. J. Environ. Anal. 816 Chem., 98, 987-1004.
35. Pirsaheb, M., Seifi, H., Dawi, E. A., Gholami, T., Badraldin, S. Q., Ryadh, A., and Salavati-Niasari, M. (2023). Thermal analysis techniques in herbal medicine: A comprehensive review on unveiling integrity and quality for future perspectives. Journal of Analytical and Applied Pyrolysis, 175, 106192.
36. Kupina, S., Fields, C., Roman, M. C., and Brunelle, S. L. (2018). Determination of total phenolic 875 content using the Folin-C assay: Single-laboratory validation, first action 2017.13. 876 Journal of AOAC International, 101(5), 1466–1472.
37. Matic, P., Sabljic, M., and Jakobek, L. (2017). Validation of Spectrophotometric Methods for the Determination of Total Polyphenol and Total Flavonoid Content. Journal of AOAC International, 100(6), 1795–1803.