ABSTRACT:
A straightforward, precise, and environmentally friendly UV spectrophotometric analytical approach was successfully developed and validated for the quantitative analysis of Furosemide in solid pharmaceutical formulations. This innovative method employs a 10% Urea solution as the hydrotropic agent, effectively enhancing the aqueous solubility of Furosemide and enabling its accurate determination. The use of Urea as a hydrotropic solvent offers a cost-effective and sustainable solution, eliminating the need for organic solvents and minimizing environmental impact. The 10% Urea solution facilitates the solubilization of Furosemide, allowing for its precise quantification. The validation of the method's optical parameters, specifically linearity, accuracy, precision, limit of detection, and limit of quantitation, was successfully conducted. The method was then effectively utilized to quantify Furosemide in two distinct commercial brands, yielding clear resolution and no interference from inactive ingredients The results showed that Brand A had a higher percentage purity (98.7%) compared to Brand B (97.3%). The developed method is applicable for the routine quantitation of Furosemide in pharmaceutical products, particularly in solid dosage forms, and can be utilized for assuring product quality through quality control measures.
Cite this article:
C G Jincy, U S Jijith, K P Arunraj. Development and Validation of an Eco-Friendly UV Spectrophotometric Method for the Assay of Frusemide using Hydrotropic Solubilization Technique. Research Journal Pharmacy and Technology. 2025;18(8):3865-0. doi: 10.52711/0974-360X.2025.00555
Cite(Electronic):
C G Jincy, U S Jijith, K P Arunraj. Development and Validation of an Eco-Friendly UV Spectrophotometric Method for the Assay of Frusemide using Hydrotropic Solubilization Technique. Research Journal Pharmacy and Technology. 2025;18(8):3865-0. doi: 10.52711/0974-360X.2025.00555 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-8-58
6. REFERENCES:
1. Tenzing, D., Suolang, P., Gesang, D. et al. Effect of furosemide in the treatment of high-altitude pulmonary edema. BMC Pulm Med. 2024; 109. https://doi.org/10.1186/s12890-024-02933-x
2. Dahiya G, Bensimhon D, Goodwin MM, Mohr JF, Alexy T. From Oral to Subcutaneous Furosemide: The Road to Novel Opportunities to Manage Congestion. Structural Heart. 2022; 6(4): 100076: doi.org/10.1016/j.shj.2022.100076
3. El-Saharty YS. Simultaneous high-performance liquid chromatographic assay of furosemide and propranolol HCL and its application in a pharmacokinetic study. J Pharm Biomed Anal. 2003; 24; 33(4): 699-709. doi: 10.1016/s0731-7085(03)00229-2. PMID: 14623596.
4. J Valarmathy, L Samueljoshua, G Rathinavel, C Selvin Thanuja, T Sivakumar. RP-HPLC Method Development and Validation for Assay of Levetiracetam in Tablet Dosage Form. Research J. Pharm. and Tech. 2008; 1(3); 395-397.
5. Sharmin Reza Chowdhury. Mahfuza Maleque, Mahbubul Hoque Shihan, Development and Validation of a Simple RP-HPLC Method for Determination of Caffeine in Pharmaceutical Dosage Forms. Asian J Pharm Ana. 2012; 2(1): 01–4.
6. Sora DI, Udrescu S, Albu F, David V, Medvedovici A. Analytical issues in HPLC/MS/MS simultaneous assay of furosemide, spironolactone and canrenone in human plasma samples. J Pharm Biomed Anal. 2010; Sep 5; 52(5): 734-40. doi: 10.1016/j.jpba.2010.03.004. Epub 2010 Mar 7. PMID: 20307949.
7. Lee J, Lee SC, Acharya G, Chang CJ, Park K. Hydrotropic solubilization of paclitaxel: analysis of chemical structures for hydrotropic property. Pharm Res. 2003; 20(7): 1022-30. doi: 10.1023/a:1024458206032. PMID: 12880288.
8. S. J. Daharwal. Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Diazepam and Propranolol in Bulk Drug and Its Formulations. Asian J. Pharm. Ana. 2013; 3(1); 20-23.
9. Harriss BI, Vella-Zarb L, Wilson C, Evans IR. Furosemide Cocrystals: Structures, Hydrogen Bonding, and Implications for Properties. Cryst Growth Des. 2014; Feb 5; 14(2): 783–9: doi.org/10.1021/cg401662d
10. Vardanyan, R.S. and Hruby, V.J. Synthesis of Essential Drugs. 1st Edition, Elsevier, Amsterdam. 2006: doi.org/10.1016/B978-044452166-8/50036-4
11. Bolukbasi O, Yilmaz A. X-ray structure analysis and vibrational spectra of Furosemide. Vib SpectroscVibrational Spectroscopy. 2012; Sept.62, 42-49. doi:10.1016/j.vibspec.2012.06.002
12. Lomba L, Polo A, Alejandre J, Martínez N, Giner B. Solubility enhancement of caffeine and furosemide using deep eutectic solvents formed by choline chloride and xylitol, citric acid, sorbitol or glucose. J Drug Deliv Sci Technol. 2023; Sept; 79: 104010. doi:10.1016/j.jddst.2022.104010
13. Minio F, Torriente AH, Balu AM, Vaccaro L, Osman SM, Luque R, et al. Benign-by-design sustainable protocol for the synthesis of furosemide. Sustain Chem Pharm. 2024; 39: 101600. doi: 10.1016/j.scp.2024.101600
14. Sharma P. Singh, S Spectrophotometric determination of Furosemide in pharmaceutical formulations using hydrotropic solubilization technique. J Pharm Biomed Sci. 2020; 10(4): 147–52.
15. Sánchez Rojas F, Bosch Ojeda C. Recent development in derivative ultraviolet/visible absorption spectrophotometry: 2004-2008: a review. Anal Chim Acta. 2009; Mar 2; 635(1): 22-44. doi: 10.1016/j.aca.2008.12.039.
16. Rajashri R. Kulkarni. Dipti G. Phadtare, Ravindra B. Saudagar, UV Spectrophotometric Method Development and Validation of Fluticasone Propionate. Asian J Res Pharm Sci 2016; 6(2): 135-138. 2016; 6(2): 135–8. doi: 10.5958/2231-5659.2016.00019.9
17. Arora B, Lather V, Pathalingappa MB, Walia R. Enhancement of aqueous solubility of hesperidin and naringenin utilizing hydrotropic solubilization technique: characterization and in vitro evaluation. J Asian Nat Prod Res. 2024; Oct; 26(10): 1207-1218. doi: 10.1080/10286020.2024.2358831.
18. Singh AK, McArdle C, Ashraf M, Granley K, Mishra U, Gordon B. Evaluation of high-performance liquid chromatography (HPLC), enzyme linked immunosorbent assay (ELISA) and particle concentration fluorescence immunoassay (PCFIA) methods for the screening, quantitation and pharmacokinetic study of furosemide in horses. Forensic Sci Int. 1990; Aug; 47(1): 1-15. doi: 10.1016/0379-0738(90)90280-c. PMID: 2210548.
19. Jain N, Jain R, Jain DK, Maheshwari RK, Jain S. Novel UV-spectrophotometric method for quantitative estimation of furazolidone using mixed hydrotropic agent. Pak J Pharm Sci. 2013; Jan; 26(1): 159-62. PMID: 23261742.
20. Ram VR, Dave PN, Joshi HS. Development and validation of a stability-indicating HPLC assay method for simultaneous determination of spironolactone and furosemide in tablet formulation. J Chromatogr Sci. 2012; Sep; 50(8): 721-6. doi: 10.1093/chromsci/bms062.PMID: 22641089.
21. K. Pramod. Shahid H. Ansari, Javed Ali, Development and validation of UV spectrophotometric method for the quantitative estimation of eugenol. Asian J Pharm Ana. 2013; 3(2): 58–61.
22. Jyoti Dahiya, Anuradha Singh, Shiv Kumar Gupta, Babita Kumar, Spectrophotometric Estimation of Dextromethorphan in Bulk Drug using Hydrotropic Solubilization Technique. Asian J Pharm Ana. 2013; 3(3): 90–3.
23. Akshay Waghmare, Ganesh Taware, Shrikrishna Baokar, Santosh Undare. Ecofriendly Validated Spectrophotometric Method for the Estimation of Amlodipine Besylate by using Hydrotropic Solubilization Method. Asian J. Pharm. Ana. 2019; 9(1): 08-10. doi: 10.5958/2231-5675.2019.00003.6
24. Ganesh Chaulang, Kundan Patil, Dhananjay Ghodke, Shagufta Khan, Pramod Yeole. Preparation and Characterization of Solid Dispersion Tablet of Furosemide with Crospovidone. Research J. Pharm. and Tech. 2008; 1(4); 386-389.
25. D. Sridharan, Umarani A. Thenmozhi, L. Pavan Kumar, Aswani Dutt Chintalapati, M. Venkata Ramanaiah, Yelika Phanikishore. Development and Validation of UV Spectrophotometric Method of Darifenacin Hydrobromide in Bulk and Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(3); 43-45.
26. Balap Aishwarya R., Prasad Deepshikha V., Khidse Anuja S., Jadhav Shailaja B., Joshi S.V., Chaudhari Praveen D. Development and Validation of Spectrophotometric Methods for Estimation of Granisetron Hydrochloride in Pure and it’s Pharmaceutical Dosage Forms. Asian J. Research Chem. 2010; 3(4); 928-931.
27. Zahid Zaheer, Obaid Shaikh, Sucheta Thorat, Rana Z. Ahmed. Development and Validation of UV Spectrophotometric Method of Fluoxetine Hydrochloride in Bulk and Pharmaceutical Formulation. Asian J. Research Chem. 2010; 3(3); 545-548.
28. Patel HM. Patel, J. A, Spectrophotometric determination of Furosemide in pharmaceutical formulations using hydrotropic solubilization technique. J Pharm Biomed Sci. 2020; 10(3): 201–6.
29. Beckett, A. H., and Stenlake, J. B. Practical Pharmaceutical Chemistry. Part 2. 4th ed. Athlone Press;1986.
30. Indian Pharmacopoeia, 8th Ed. Government of India, Indian pharmacopeial commission, New Ghaziabad, Vol. II1, 2018, 948.
31. Chatwal, G. R., and Anand, S. K. Spectrophotometry and Spectro fluorimetry in Pharmaceutical Analysis. 2nd ed. CBS Publishers and Distributors; 2001.