DEVELOPMENT, EVALUATION AND RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF QUERCETIN, ELLAGIC ACID AND KAEMPFEROL IN A POLYHERBAL FORMULATION
Objective: The current study was planned to develop polyherbal tablet formulation, standardization and evaluation for mitigating the symptoms of polycystic ovarian syndrome (PCOS). To control the issue of PCOS in women by the utilization of newly developed polyherbal tablet formulation.
Methods: The polyherbal tablets were prepared using a hydroalcoholic extract of the selected medicinal plants viz. Asparagus racemosus, Bauhinia variegata, Caesalpinia bonducella, Saraca asoca, and Symplocos racemosa with the help of a super disintegrant addition technique using crospovidone, kyron T-314 and pregelatinized starch in various percentages. Evaluation assessments such as pre-formulation studies, weight variation, hardness, friability, thickness, disintegration, IR compatibility and simultaneous estimation of quercetin, ellagic acid and kaempferol by RP-HPLC method were done.
Results: The results reveal that preformulation and evaluation parameters were satisfactory and found to be within an acceptable limit. The Fourier transform infrared spectroscopy (FTIR) compatibility displays no chemical interaction amongst the hydroalcoholic extract of polyherbal formulation and excipients. In simultaneous estimation, the retention time of quercetin, ellagic acid, and kaempferol were found to be 4.86, 6.96 and 10.01 min respectively. The linearity of quercetin, ellagic acid and kaempferol were found in the range of 0-200 µg/ml with correlation coefficients (R2>0.997) within the tested ranges. The LOD and LOQ values of quercetin, ellagic acid and kaempferol were found to be 11.86, 2.63, 5.28 µg/ml and 35.95, 7.98, 16.00 µg/ml respectively. The % RSD values were found to be less than 2 showed the optimized method is precise.
Conclusion: To conclude, the prepared polyherbal tablet and its quality control analysis revealed satisfactory pharmaceutical properties that fulfill within the limits of pharmacopeial standards. The RP-HPLC method for simultaneous estimation of quercetin, ellagic acid and kaempferol were simple, precise, accurate and consistent for the quantitative analysis and quality control examination of herbal formulations.
2. Kabayundo J, Muganga R, Humura F, Abila DB, Micheal AI. The impact of herbal medicines uses in patients under highly active antiretroviral therapy in rwanda. Int J Pharm 2020;10:1–10.
3. Karole S, Shrivastava S, Thomas S, Soni B, Khan S, Dubey J, et al. Polyherbal formulation concept for synergic action: a review. J Drug Delivery Ther 2019;9:453–66.
4. Chimagave SS, Jalalpure SS, Kurangi BK. Preparation and development of polyherbal formulation of medicinal plants for antiarthritic activity. Indian J Health Sci Biomed Res 2020;13:120-6.
5. Awasthi H, Mani D, Nath R, Nischal A, Usman K, Khattri S. Standardization, preparation and evaluation of an ayurvedic polyherbal formulation in capsule dosage form suitable for use in clinical trials. Indo Am J Pharm Res 2014;4:4093-39.
6. Majumder P, Paridhavi M. Physiocochemical standardization and formulation development of poly-herbal tablet for diabetes. Br J Pharm Res 2016;12:1–17.
7. Hamrah KTKA, Al-Shaibani AJN, Al-Edresi SS, Al-Gburi KMH. A comparative study of quality control testing on candesartan cilexetil conventional tablets in Iraq. Int J Appl Pharm 2020;12:103–8.
8. Odani N, Mohan S, Kato E, Feng H, Li Y, Hossain MN, et al. Determining the effect of photodegradation on film coated nifedipine tablets with terahertz-based coating thickness measurements. Eur J Pharm Biopharm 2019;145:35–41.
9. Shaikh S, Jain V. Development and validation of novel RP-HPLC method for the simultaneous estimation of ellagic acid and quercetin in an ayurvedic formulation. Int J Appl Pharm 2018;10:111–6.
10. Nuzhat Qureshi, Raghvendra Dubey, Nilesh Kumar Pathak. Polyherbal preparation and comparative studies on diet-induced hyperlipidemia. Asian J Pharm Clin Res 2019;12:190–6.
11. Agnihotri A, Singh V. Formulation development and evaluation of antidiabetic polyherbal tablet. J Pharm Innov 2014;3:1–3.
12. Maurya H, Kumar T. Formulation, standardization, and evaluation of polyherbal dispersible tablet. Int J Appl Pharm 2019;11:158–67.
13. Navamanisubramanian R, Nerella R, Seetharaman S. Pharmacokinetic investigation to study the in vivo bioavailability of thiolated chitosan based repaglinide buccal tablets. Pharm Sci 2020;26:414–22.
14. Pamu Poornima, Karra Geetha, Pamu Sandhya. Evaluation of cetrizine hydrochloride–loaded orally disintegrating tablets for disintegration time and dissolution studies. Int J Pharm 2019;9:10-9.
15. Dinakaran SK, Sujiya B, Avasarala H. Profiling and determination of phenolic compounds in Indian marketed hepatoprotective polyherbal formulations and their comparative evaluation. J Ayurveda Integr Med 2018;9:3–12.
16. Vasanth MP, Purushotham KG. Screening of phytochemical analysis and in vitro bioactive of polyherbal formulation. Pharmacogn J 2020;12:1525–33.
17. Chandra Sekhar Naik D, Bharathi A, Basaveswara Rao MV. Design and formulation development of fast-dissolving tablets of ibuprofen using novel natural super disintegrant. Asian J Pharm Clin Res 2019;12:34–41.
18. Nath J. Formulation and in vitro evaluation of curcumin loaded jackfruit seed starch nanoparticles. Int J Curr Pharm Res 2020;12:32–5.
19. Senthil Rajan D, Muruganathan G, Shivkumar K, Thangavel G. Development and validation of hplc method for simultaneous quantification of vasicine, glycyrrhizin and piperine in poly herbal cough syrup. Int J Curr Pharm Res 2020;12:15–9.
20. Bhat MH, Fayaz M, Kumar A, Dar AA, Jain AK. Chromatographic method for determination of the amino acid content in Dioscorea bulbifera L. tubers by RP-HPLC Pharm Sci 2019;25:65–9.
21. Yaripour S, Mohammadi A, Mousavi S, Esfanjani I, Arabzadeh N, Mozaffari S. Simultaneous determination of 2-nitrophenol and 4-nitrophenol in pharmaceutical industrial wastewater by electromembrane extraction coupled with HPLC-UV analysis. Pharm Sci 2019;25:57–64.
22. Ghosh VK, Bhope SG, Kuber VV, Gaikwad PS, Patil MJ. Development and validation of dissolution test method for andrographolide from film coated polyherbal tablet formulation. Int J Phar Pharm Sci 2012;4:307-12.
23. Zhu H, Wang Y, Liang H, Chen Q, Zhao P, Tao J. Identification of portulaca oleracea L. from different sources using GC-MS and FT-IR spectroscopy. Talanta 2010;81:129–35.
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