Author(s):
Deep Savsani, Mitali Dalwadi, Priyanka Patil, Umesh Upadhyay
Email(s):
deepsavsani123@gmail.com , mitaliswami7@gmail.com , priyanka.ph@sigmauniversity.ac.in , umesh.ph@sigmauniversity.ac.in
DOI:
10.52711/0974-360X.2026.00449 
Address:
Deep Savsani1*, Mitali Dalwadi1, Priyanka Patil2, Umesh Upadhyay3
1PG Scholar, M.Pharm (Q.A.), Sigma Institute of Pharmacy, (Faculty of Pharmacy), Sigma University, Bakrol, Vadodara – 390019.
1Assistant Professor, Sigma Institute of Pharmacy, Sigma University, Bakrol, Vadodara – 390019.
2Dean, Sigma Institute of Pharmacy, Sigma University.
3ProVC, Sigma University Bakrol, Vadodara – 390019.
*Corresponding Author
Published In:
Volume - 19,
Issue - 7,
Year - 2026
ABSTRACT:
Robust RP-HPLC method was established and validated for the simultaneous quantification of Fimasartan potassium trihydrate and Indapamide in a synthetic mixture. Analytes were separated on a C18 column with a mobile phase of phosphate buffer (pH 3.5), methanol, and acetonitrile (45:25:30 v/v/v) at 1.0mL/min, and detected at 248nm. The method showed excellent linearity, precision, and accuracy across the tested concentration ranges, with low LOD and LOQ values. System suitability and specificity were confirmed, including successful separation of both drugs from their degradation products under various stress conditions. The validated method is rapid, sensitive, and suitable for stability and quality control studies of these antihypertensive agents in combination. The developed method also adheres to green analytical chemistry principles. It minimizes solvent consumption and environmental impact while ensuring reliable performance.
Cite this article:
Deep Savsani, Mitali Dalwadi, Priyanka Patil, Umesh Upadhyay. A Green and Stability-Indicating RP-HPLC Approach for the Quantification of Fimasartan Potassium Trihydrate and Indapamide in Synthetic Mixtures. Research Journal of Pharmacy and Technology. 2026;19(7):3162-8. doi: 10.52711/0974-360X.2026.00449
Cite(Electronic):
Deep Savsani, Mitali Dalwadi, Priyanka Patil, Umesh Upadhyay. A Green and Stability-Indicating RP-HPLC Approach for the Quantification of Fimasartan Potassium Trihydrate and Indapamide in Synthetic Mixtures. Research Journal of Pharmacy and Technology. 2026;19(7):3162-8. doi: 10.52711/0974-360X.2026.00449 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-7-36
REFERENCES:
1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q2(R2): Validation of analytical procedures. Geneva: ICH; 2023.
2. Patel A, Dave JB, Patel CN. Stability-indicating RP-HPLC method for simultaneous estimation of antihypertensive drug combinations. International Journal of Pharmaceutical Sciences and Research. 2017; 8(5): 2112–2118.
3. Rao RN, Narsimha R, Sravan B, Raju AN. Development and validation of a stability-indicating LC method for Fimasartan in bulk and pharmaceutical dosage forms. Journal of Pharmaceutical and Biomedical Analysis. 2011; 56(4): 835-840. doi: 10.1016/j.jpba.2011.07.027.
4. Garg R, Sharma A, Lata S, Sharma AK. RP-HPLC method development and validation for estimation of Indapamide in bulk and tablet dosage forms. International Journal of Pharmaceutical Sciences and Research. 2014; 5(11): 4891-4896. doi:10.13040/IJPSR.0975-8232.5(11).4891-96
5. Snyder LR, Kirkland JJ, Dolan JW. Introduction to Modern Liquid Chromatography. 3rd ed. John Wiley and Sons; 2010.
6. Prashanthi D, Ramesh B, Manish M. Development of Novel Validated RP HPLC Method for the simultaneous determination of Perindropil and Amlodipine with possible degradants in Fixed dose Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2022; 15(10): 4509–4514. doi:10.52711/0974 360X.2022.00756.
7. Chhabra GS, Rajora A, Mishra DK. Stability indicating RP HPLC method for the determination of Tenofovir in pharmaceutical formulation. Research Journal of Pharmacy and Technology. 2021; 14(12): 6335–6339. doi:10.52711/0974 360X.2021.01095.
8. B. Srinivas. Validated Stability Indicating Reverse Phase HPLC Method for the Simultaneous Estimation of Perindopril and Indapamide in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2020; 13(5): 2163–2166. doi:10.5958/0974 360X.2020.00389.3.
9. Mookambika A, Dhanaraj SA. Development and Validation of RP-HPLC Method for the Estimation of Fimasartan in Tablet Dosage Form. Res J Pharm Technol. 2023; 16(1): 197–202. doi:10.52711/0974-360X.2023.00034
10. Narayanaswamy VK, Swamy RS. Analytical Method Development and Validation of Fimasartan Potassium Trihydrate by RP-HPLC. Res J Pharm Technol. 2022; 15(9): 4003–4007. doi:10.52711/0974-360X.2022.00671
11. Mehta RS, Shah VM. Stability Indicating RP-HPLC Method for Simultaneous Estimation of Telmisartan and Indapamide in Pharmaceutical Dosage Form. Res J Pharm Technol. 2021; 14(11): 5941–5946. doi:10.52711/0974-360X.2021.01030
12. Rani N, Kumar V. Simultaneous Estimation of Indapamide and Nebivolol in Bulk and Tablet Dosage Form using RP-HPLC Method. Res J Pharm Technol. 2022; 15(12): 5423–5427. doi:10.52711/0974-360X.2022.00913
13. Joshi D, Patel H. Development and Validation of Analytical Method for Estimation of Fimasartan in Pharmaceutical Dosage Form. Res J Pharm Technol. 2022; 15(3): 1259–1263. doi:10.52711/0974-360X.2022.00211
14. Thakur GS, Gaurav A. Analytical Method Development and Validation for Estimation of Indapamide by RP-HPLC. Res J Pharm Technol. 2021; 14(4): 2059–2063. doi:10.52711/0974-360X.2021.00363
15. Shaikh KA, Devadhe SJ. A Review on Analytical Method Development and Validation for Estimation of Fimasartan. Res J Pharm Technol. 2023; 16(6): 2595–2599. doi:10.52711/0974-360X.2023.00433
16. Yadav A, Bhatt A. Validated RP-HPLC Method for Simultaneous Estimation of Fimasartan and Hydrochlorothiazide in Tablet Dosage Form. Res J Pharm Technol. 2021; 14(9): 4885–4890. doi:10.52711/0974-360X.2021.00848
17. Mishra S, Patel P. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Fimasartan and Indapamide in Tablet Formulation. Res J Pharm Technol. 2022; 15(5): 2097–2102. doi:10.52711/0974-360X.2022.00348
18. Raval P, Parmar R. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fimasartan in Bulk and Tablet Dosage Form. Res J Pharm Technol. 2021; 14(8): 4299–4303. doi:10.52711/0974-360X.2021.00749
19. Kulkarni AS, Muley BA. Stability Indicating Method Development and Validation for Estimation of Indapamide using RP-HPLC. Res J Pharm Technol. 2020; 13(12): 5791–5795. doi:10.5958/0974-360X.2020.01011.3
20. Shah K, Joshi M. Simultaneous Estimation of Indapamide and Amlodipine in Bulk and Tablet Dosage Form by RP-HPLC. Res J Pharm Technol. 2020; 13(6): 2769–2774. doi:10.5958/0974-360X.2020.00485.6
21. Akabari AH, Patel P, Darji H, et al. Simultaneous estimation of Fimasartan potassium trihydrate and Atorvastatin calcium with greenness assessment using HPLC and UV spectrophotometric methods. Green Anal Chem. 202310.1016.
22. Rabadiya VA. Eco-Friendly RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Indapamide: Analytical Quality by Design Approach and Greenness Assessment. Sustain Sci Pract Chem Process (SSCP). 2025.
23. Bansal A, Gupta S. Green RP-HPLC Method Development and Validation for Estimation of Indapamide and Fimasartan. Res J Pharm Technol. 2023; 16(4): 1695–1700. doi:10.52711/0974-360X.2023.00282.
24. Darji H, Patel P, Shah H, et al. Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan. Future J Pharm Sci. 2025; 11: 760.
25. Darji H, Dedania Z, Dedania R, Jain V. Eco-friendly based HPLC and UV-spectrophotometric methods for simultaneous estimation of Efonidipine hydrochloride Ethanolate and Chlorthalidone in their dosage form. Green Anal Chem. 2024; 8:100092.
26. Darji H, Jain V, Patel P, Shah H. Simultaneous estimation of Azelnidipine and Metoprolol succinate with greenness assessment using HPLC and UV-spectrophotometric methods. Green Anal Chem. 2023; 7:100079.