A SYSTEMATIC REVIEW ON ANALYTICAL METHOD FOR THE ESTIMATION OF FINERENONE AND EMPAGLIFLOZIN
Main Article Content
Keywords
Finerenone, Empagliflozin, T2DM, CKD, Analytical method, HPLC, LC – MS/MS, Spectrophotometry, Bioanalytical method.
Abstract
This review focuses on analytical methods for finerenone, a non-steroidal mineralocorticoid receptor antagonist, and empagliflozin, a selective SGLT2 inhibitor, used in the management of type 2 diabetes mellitus with chronic kidney disease. Accurate estimation of these drugs is essential for pharmacokinetics, clinical monitoring, and quality control. Finerenone is mainly analyzed using chromatographic techniques such as HPLC, UHPLC, and LC–MS/MS, while empagliflozin is frequently estimated by spectrophotometric, chromatographic, and hyphenated methods, with LC–MS/MS being the most sensitive in biological matrices. This review critically evaluates reported analytical approaches, comparing their applicability, advantages, and limitations, and highlights the future scope for developing robust, cost-effective, and regulatory-compliant methods.
References
1. K.J. Jager, et al., A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int 2019;96, (5) 1048–1050.
2. A systematic analysis for the Global Burden of Disease Study 2017. Lancet, 2020;709–733.
3. Afkarian M, Sachs MC, Kestenbaum B et al. kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol 2013; 24:302-8
4. KDIGO. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2012;3(1):1–150.
5. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int suppl. 2024; 105: S117–314
6. Chronic kidney disease and risk management: standards of care in diabetes2025. Diabetes Care 2025; 48: S239–51.
7. The EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. N Engl J Med 2023; 388: 117–27.
8. Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019; 380: 2295–306.
9. Green JB, Mottl AK, Bakri's G et al. Design of the Combination effect of Finerenone and Empagliflozin in participants with chronic kidney disease and type 2 diabetes using a UACR End- point study (CONFIDENCE). Nephrol Dial Transplant 2023; 38 :894 903.
10. Eising T, Goulooze SC, van den Berg P et al. Pharmacokinetics and pharmacodynamics of finerenone in patients with chronic kidney disease and type 2 diabetes: insights based on FIGARO- DKD and FIDELIO-DKD. Diabetes Obes Metab 2024; 26 :924–36.
11. Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2016 Mar 17; 374(11): 1094.
12. Wanner C, Inzucchi SE, Zinman B. Empa gliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016 Nov 3; 375(18): 323–34
13. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020 Oct 8; 383(15): 1413–24
14. Ali Irtaza Rizvi, Sadia Ali, Rabia Arooj, Muhammad Asim, Ramsha Nawaz, Sadia Zakir, Ammarah Mushtaq, Maleesha Manzoor, Rabail Afzal, Nimra hanif, Muneeba Rasool, Critical Review of CKD Medications in Cardiovascular Disease: Biochemical Effects and Therapeutic Implications. Pak-Euro Journal of Medical and Life Sciences 2025, 8(1),77-92.
15. ElSayed NA, Bannuru RR, Bakri's G et al. Diabetic kidney dis- ease prevention care model development. Clin Diabetes 2024; 42: 274–94
16. Green JB, Mottl AK, Bakri's G et al. Design of the Combination effect of Finerenone and Empagliflozin in participants with chronic kidney disease and type 2 diabetes using a UACR End- point study (CONFIDENCE). Nephrol Dial Transplant 2023; 38 :894 903.
17. P.Grubi’c Rotkvi´c, et al., Sodium-glucose cotransporter 2 inhibitors’ mechanisms of action in heart failure, World J. Diabetes 2020 11 (7) 269–279.
18. Emily Ashjian, Megan Clarke, Kristen Pogue, “Pharmacotherapy considerations with finerenone in the treatment of chronic kidney disease associated with type 2 diabetes”, American Journal of Health-System Pharmacy, 2023, 80(23), 1708–1721.
19. Agarwal R, Green JB, Heerspink HJL, et al. Finerenone with empagliflozin in chronic kidney disease and type 2 diabetes. N Engl J Med. 2025;393(6):533–543
20. Bakri's GL, Agarwal R, Anker SD, et al.: Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020, 383:2219-29.
21. Zhang Y, Jiang L, Wang J, et al.: Network meta-analysis on the effects of finerenone versus SGLT2 inhibitors and GLP-1 receptor agonists on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus and chronic kidney disease. Cardiovasc Diabetol. 2022, 21:232.
22. Heng Zhong, Bin-Hong Duan, Fu-Man Du, Wei-Min Wang, Hong Qiao, “Identification of key genes, biological functions, and pathways of empagliflozin by network pharmacology and its significance in the treatment of type 2 diabetes mellitus”, Annals of Translational Medicine, 2023, 11(2), 123.
23. Peter Kolkhof, Elke Hartmann, Alexius Freyberger, Mira Pavkovic, Ilka Mathar, Peter Sandner, Karoline Droebner, Amer Joseph, Jörg Hüser, Frank Eitner, “Effects of Finerenone Combined with Empagliflozin in a Model of Hypertension-Induced End- Organ Damage”, American Journal of Nephrology, 2021, 52(8), 642–652.
24. Manoel, J.W.; Primieri, G.B.; Bueno, L.M.; Wingert, N.R.; Volpato, N.M.; Garcia, C.V.; Steppe, M. The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities. Royal Society of Chemistry Adv. 2020, 10, 7313–7320.
25. Baigent C, Emberson Jonathan R, Haynes R, et al. Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. Lancet. 2022;400(10365):1788–1801.
26. Rossing P, Anker SD, Filippatos G, et al. Finerenone in patients with chronic kidney disease and type 2 diabetes by sodium-glucose cotransporter 2 inhibitor treatment: the FIDELITY analysis. Diabetes Care. 2022, 45:2991-8.
27. Arsalan M, Jabeen M, Begum H. Liquid Chromatography Method Development and Validation for the Quantitative Determination of Finerenone in Bulk Drug and Pharmaceutical Formulation. TIJER-International research journals. 2023; 10:758-762.
28. Murugesan A, Mukthinuthalapati A. Forced Degradation Studies for Estimation of Finerenone by RP-HPLC Method. Acta Scientific Pharmaceutical Sciences.2021; 5:25-31.
29. Husnain, F., Mahboob, P. & Khaleel, M. Estimation and validation of finerenone in dosage form and in bulk drug by spectrophotometric method. Indian Journals 2023, 16, 211–215.
30. Shaik Bima Benazir, Jorige Archana, Mogili Sumakanth. Method Development and Validation of Empagliflozin in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):123-6.
31. Sushil D. Patil, Sayali K. Chaure, Maswood Ahmed Hafizur Rahman, Prajkta U. Varpe, Sanjay Kshirsagar. Development and Validation of Simple UV- Spectrophotometric Method for the Determination of Empagliflozin. Asian J. Pharm. Ana. 2017; 7(1): 18-22.
32. Syrgabek, Y., Alimzhanova, M., García-Encina, P. A., Jiménez, J. J. & López-Serna, R. Greenness evaluation of sample Preparation methods by GAPI for the determination of pesticides in grape: A review. Trends Environ. Anal. Chem. 2023, (39), e00206.
33. Mansour, F. R., Bedair, A. & Locatelli, M. Click analytical chemistry index as a novel concept and framework, supported with open-source software to assess analytical methods. Adv. Sample Preparation. 2025 (14), 100164.
34. Rohde, G., Loewen, S. & Heinig, R. Determination of finerenone–a novel, selective, nonsteroidal mineralocorticoid receptor antagonist–in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application to a Pharmacokinetic study in venous and capillary human plasma. J. Chromatogr. B. 2021,1172, 122643.
35. VARADE, M. M, Patill, P. R. &Jadhav, R.G. RP-HPLC method development and validation of finerenone in bulk drug and its formulation. GSC Bio.Pharm.Sci.2024;27,214-222.
36. Donepudi Sharmila, Achanta Suneeta. Validated HPLC-UV method for simultaneous estimation of Linagliptin and empagliflozin in Human plasma. Int J Appl Pharm 2018; 10:56-61
37. Madana Gopal N, Sridhar C. A validated the stability-indicating ultra-performance liquid chromatographic method for simultaneous determination of metformin hydrochloride and empagliflozin in bulk drug and tablet dosage form. Int J Appl Pharm 2017; 9:45-50.
38. Ayoub, B.M. UPLC simultaneous determination of empagliflozin, linagliptin and metformin. Royal Society of Chemistry Advances, 2015, 5(116).
39. Shah, Priyanka A, Pranav S. Shrivastav, and Archana George. Mixed-mode solid phase extraction combined with LC-MS/MS for determination of empagliflozin and linagliptin in human plasma. Micro chemical Journal. 2019; 145:523-531
40. k. Branch, S. Guidelines from the international conference on harmonisation (ICH).J.Pharm.Biomedical Anal.2005; 38, 798–805.
41. Imran, S. J. et al. Validated stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) for the Estimation of finerenone in pharmaceutical tablet dosage form. Europe PMC 2023;46.
42. Jyothi Mirzapur, Gade Sammaiah et al. development and validation of new analytical RP HPLC method for the quantitative estimation of finerenone . Int. J. of Allied Med. Sci. and Clin. Research Vol-11(2) 2023 [210-218]
43. Chhetri HP, Thapa P, Van Schepdael A Simple HPLC-UV method for the quantification of metformin in human plasma with one step protein precipitation. Saudi Pharm J .2014;22(5):483–487.
44. Mabrouk, M.M.; Soliman, S.M.; El-gizy, H.M.; Mansour, F.R. A UPLC/DAD method for simultaneous determination of empagliflozin and three related substances in spiked human plasma. BMC Chem., 2019, 13(1), 83.
45. Reddy, Y. V., Nayak, A., Sangeetha, G., Deepa, M. & Kumta, R. Analytical quality by design approaches to RP-HPLC method development validation and stability indicating assay for the determination of finerenone in bulk drug. BioChem. Cell. Archives. 2024;24, 2331.
46. Rao, M.S.; Rambhau, D.K. Development and validation for the simultaneous estimation in of metformin and empagliflozin in drug product by RP-HPLC. European J. Biomed. Pharma. Sci., 2018, 5(2), 404-410.
47. Adaway JE, Keevil BG. Therapeutic drug monitoring and LC MS/MS. Journal of Chromatography B. 2022 Feb 1;883:33-49.
48. Thallapalli, A.K.G.; Manda, R.M. Development and validation of empagliflozin and linagliptin simultaneous estimation in rat plasma using freezing lipid precipitation and SCX-SPE assisted HPLC MS/MS method and its application in pharmacokinetic studies. Anal. Sci., 2024, 40(1), 185-198.
49. Vijaya, V.; Ujjwala, K.; Pallavi, D.; Choudhari, V.P. Development of validated RP-HPLC method for estimation of empagliflozin and metformin in combined formulation. J. Pharm. Res. Int., 2021, 33(60A), 1-7.
50. Epshtein, N., Sevast’yanova, V. & Koroleva, A. Validation of Related-Substances determination methods for detecting unidentified substances (A Review). Pharm. Chem. J.2020; 54, 959–967.
51. Rohde g, Lowen S, R. Determination of finerenone Anovel, selective non-steroidal receptor antagonist- in human plasma by HPLC tandem mass spectrometry and its application to pharmacokinetics study in plasma, J Chromatogr. B Analyst technol biomed life sci 2021, May 153.
52. Adaway JE, Keevil BG. Therapeutic drug monitoring and LC-MS/MS. Journal of chromatography B.;2022 feb 1;883:33-49.
53. Metkari, V. B. Mrs. Vanita Gade. method development and validation of finerenone by RP-HPLC method. Int. J. Innovative Res. Technol. 2024;11, 751–761.
54. Finotti Cordeiro, C., Franco, L., Teixeira Carvalho, L. & Bonfilio, R. D. Impurities in active pharmaceutical ingredients and drug products: A critical review. Anal. Chemistry, 2024, 1–21.
55. Locatelli, M. et al. green profile tools: Current status and future perspectives. Adv. Sample Preparation. 2023; 6-16
56. Ayoub, B.M.; Mowaka, S.; Elzanfaly, E.S.; Ashoush, N.; Elmazar, M.M.; Mousa, S.A. Pharmacokinetic evaluation of empagliflozin in healthy Egyptian volunteers using LC-MS/MS and comparison with other ethnic populations. Sci. Rep., 2017, 7(1), 2583.
57. International conference on harmonization, ICH guidelines, Validation of analytical procedures technical requirements for registration of pharmaceuticals for human Use: Text and Methodology Q2 (R1), international conference on Harmonization, Geneva, Swizerland.2005.
58. Plotkar Wasylak J. & Wojnowski, W. Complementary green analytical procedure index (Complex GAPI) and software. Green Chem.2021 23, 8657–8665.
59. Teasdale, A., Elder, D., Harvey, J. & Spanhaak, S. Impurities in new drug substances and new drug products: ICH Q3A/B: key guidelines in the general impurity management process. ICH Qual. Guidelines: Implement. Guide, 2017;6, 167–198.
60. Kraus Bj, Weir MR, Bakri's GL et al. Characterization and implications of the initial estimated glomerular filtration rate dip upon sodium-glucose contransporter-2inhibiton with empagliflozin in the EMPA-REG OUTCOME. Trial. Kidney int. 2021; 99:750-62.
61. Agarwal R, Tu W, Farjat AE et al. Impact of finerenone- induced albuminuria reduction on chronic kidney disease out- comes in type 2 diabetes: a mediation analysis. Ann Intern Med 2023; 176 :1606–16.
62. Stachteas P, Nasoufidou A, Patoulias D, et al. The role of sodium-glucose Co-transporter-2 inhibitors on diuretic resistance in heart failure. Int J Mol Sci. 2024;25(6):3122
63. Badve SV, Bilal A, Lee MMY, et al. Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomized controlled trials. Lancet Diabetes Endocrinol. 2025;13 (1):15–28.
2. A systematic analysis for the Global Burden of Disease Study 2017. Lancet, 2020;709–733.
3. Afkarian M, Sachs MC, Kestenbaum B et al. kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol 2013; 24:302-8
4. KDIGO. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2012;3(1):1–150.
5. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int suppl. 2024; 105: S117–314
6. Chronic kidney disease and risk management: standards of care in diabetes2025. Diabetes Care 2025; 48: S239–51.
7. The EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. N Engl J Med 2023; 388: 117–27.
8. Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019; 380: 2295–306.
9. Green JB, Mottl AK, Bakri's G et al. Design of the Combination effect of Finerenone and Empagliflozin in participants with chronic kidney disease and type 2 diabetes using a UACR End- point study (CONFIDENCE). Nephrol Dial Transplant 2023; 38 :894 903.
10. Eising T, Goulooze SC, van den Berg P et al. Pharmacokinetics and pharmacodynamics of finerenone in patients with chronic kidney disease and type 2 diabetes: insights based on FIGARO- DKD and FIDELIO-DKD. Diabetes Obes Metab 2024; 26 :924–36.
11. Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2016 Mar 17; 374(11): 1094.
12. Wanner C, Inzucchi SE, Zinman B. Empa gliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016 Nov 3; 375(18): 323–34
13. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020 Oct 8; 383(15): 1413–24
14. Ali Irtaza Rizvi, Sadia Ali, Rabia Arooj, Muhammad Asim, Ramsha Nawaz, Sadia Zakir, Ammarah Mushtaq, Maleesha Manzoor, Rabail Afzal, Nimra hanif, Muneeba Rasool, Critical Review of CKD Medications in Cardiovascular Disease: Biochemical Effects and Therapeutic Implications. Pak-Euro Journal of Medical and Life Sciences 2025, 8(1),77-92.
15. ElSayed NA, Bannuru RR, Bakri's G et al. Diabetic kidney dis- ease prevention care model development. Clin Diabetes 2024; 42: 274–94
16. Green JB, Mottl AK, Bakri's G et al. Design of the Combination effect of Finerenone and Empagliflozin in participants with chronic kidney disease and type 2 diabetes using a UACR End- point study (CONFIDENCE). Nephrol Dial Transplant 2023; 38 :894 903.
17. P.Grubi’c Rotkvi´c, et al., Sodium-glucose cotransporter 2 inhibitors’ mechanisms of action in heart failure, World J. Diabetes 2020 11 (7) 269–279.
18. Emily Ashjian, Megan Clarke, Kristen Pogue, “Pharmacotherapy considerations with finerenone in the treatment of chronic kidney disease associated with type 2 diabetes”, American Journal of Health-System Pharmacy, 2023, 80(23), 1708–1721.
19. Agarwal R, Green JB, Heerspink HJL, et al. Finerenone with empagliflozin in chronic kidney disease and type 2 diabetes. N Engl J Med. 2025;393(6):533–543
20. Bakri's GL, Agarwal R, Anker SD, et al.: Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020, 383:2219-29.
21. Zhang Y, Jiang L, Wang J, et al.: Network meta-analysis on the effects of finerenone versus SGLT2 inhibitors and GLP-1 receptor agonists on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus and chronic kidney disease. Cardiovasc Diabetol. 2022, 21:232.
22. Heng Zhong, Bin-Hong Duan, Fu-Man Du, Wei-Min Wang, Hong Qiao, “Identification of key genes, biological functions, and pathways of empagliflozin by network pharmacology and its significance in the treatment of type 2 diabetes mellitus”, Annals of Translational Medicine, 2023, 11(2), 123.
23. Peter Kolkhof, Elke Hartmann, Alexius Freyberger, Mira Pavkovic, Ilka Mathar, Peter Sandner, Karoline Droebner, Amer Joseph, Jörg Hüser, Frank Eitner, “Effects of Finerenone Combined with Empagliflozin in a Model of Hypertension-Induced End- Organ Damage”, American Journal of Nephrology, 2021, 52(8), 642–652.
24. Manoel, J.W.; Primieri, G.B.; Bueno, L.M.; Wingert, N.R.; Volpato, N.M.; Garcia, C.V.; Steppe, M. The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities. Royal Society of Chemistry Adv. 2020, 10, 7313–7320.
25. Baigent C, Emberson Jonathan R, Haynes R, et al. Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. Lancet. 2022;400(10365):1788–1801.
26. Rossing P, Anker SD, Filippatos G, et al. Finerenone in patients with chronic kidney disease and type 2 diabetes by sodium-glucose cotransporter 2 inhibitor treatment: the FIDELITY analysis. Diabetes Care. 2022, 45:2991-8.
27. Arsalan M, Jabeen M, Begum H. Liquid Chromatography Method Development and Validation for the Quantitative Determination of Finerenone in Bulk Drug and Pharmaceutical Formulation. TIJER-International research journals. 2023; 10:758-762.
28. Murugesan A, Mukthinuthalapati A. Forced Degradation Studies for Estimation of Finerenone by RP-HPLC Method. Acta Scientific Pharmaceutical Sciences.2021; 5:25-31.
29. Husnain, F., Mahboob, P. & Khaleel, M. Estimation and validation of finerenone in dosage form and in bulk drug by spectrophotometric method. Indian Journals 2023, 16, 211–215.
30. Shaik Bima Benazir, Jorige Archana, Mogili Sumakanth. Method Development and Validation of Empagliflozin in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):123-6.
31. Sushil D. Patil, Sayali K. Chaure, Maswood Ahmed Hafizur Rahman, Prajkta U. Varpe, Sanjay Kshirsagar. Development and Validation of Simple UV- Spectrophotometric Method for the Determination of Empagliflozin. Asian J. Pharm. Ana. 2017; 7(1): 18-22.
32. Syrgabek, Y., Alimzhanova, M., García-Encina, P. A., Jiménez, J. J. & López-Serna, R. Greenness evaluation of sample Preparation methods by GAPI for the determination of pesticides in grape: A review. Trends Environ. Anal. Chem. 2023, (39), e00206.
33. Mansour, F. R., Bedair, A. & Locatelli, M. Click analytical chemistry index as a novel concept and framework, supported with open-source software to assess analytical methods. Adv. Sample Preparation. 2025 (14), 100164.
34. Rohde, G., Loewen, S. & Heinig, R. Determination of finerenone–a novel, selective, nonsteroidal mineralocorticoid receptor antagonist–in human plasma by high-performance liquid chromatography-tandem mass spectrometry and its application to a Pharmacokinetic study in venous and capillary human plasma. J. Chromatogr. B. 2021,1172, 122643.
35. VARADE, M. M, Patill, P. R. &Jadhav, R.G. RP-HPLC method development and validation of finerenone in bulk drug and its formulation. GSC Bio.Pharm.Sci.2024;27,214-222.
36. Donepudi Sharmila, Achanta Suneeta. Validated HPLC-UV method for simultaneous estimation of Linagliptin and empagliflozin in Human plasma. Int J Appl Pharm 2018; 10:56-61
37. Madana Gopal N, Sridhar C. A validated the stability-indicating ultra-performance liquid chromatographic method for simultaneous determination of metformin hydrochloride and empagliflozin in bulk drug and tablet dosage form. Int J Appl Pharm 2017; 9:45-50.
38. Ayoub, B.M. UPLC simultaneous determination of empagliflozin, linagliptin and metformin. Royal Society of Chemistry Advances, 2015, 5(116).
39. Shah, Priyanka A, Pranav S. Shrivastav, and Archana George. Mixed-mode solid phase extraction combined with LC-MS/MS for determination of empagliflozin and linagliptin in human plasma. Micro chemical Journal. 2019; 145:523-531
40. k. Branch, S. Guidelines from the international conference on harmonisation (ICH).J.Pharm.Biomedical Anal.2005; 38, 798–805.
41. Imran, S. J. et al. Validated stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) for the Estimation of finerenone in pharmaceutical tablet dosage form. Europe PMC 2023;46.
42. Jyothi Mirzapur, Gade Sammaiah et al. development and validation of new analytical RP HPLC method for the quantitative estimation of finerenone . Int. J. of Allied Med. Sci. and Clin. Research Vol-11(2) 2023 [210-218]
43. Chhetri HP, Thapa P, Van Schepdael A Simple HPLC-UV method for the quantification of metformin in human plasma with one step protein precipitation. Saudi Pharm J .2014;22(5):483–487.
44. Mabrouk, M.M.; Soliman, S.M.; El-gizy, H.M.; Mansour, F.R. A UPLC/DAD method for simultaneous determination of empagliflozin and three related substances in spiked human plasma. BMC Chem., 2019, 13(1), 83.
45. Reddy, Y. V., Nayak, A., Sangeetha, G., Deepa, M. & Kumta, R. Analytical quality by design approaches to RP-HPLC method development validation and stability indicating assay for the determination of finerenone in bulk drug. BioChem. Cell. Archives. 2024;24, 2331.
46. Rao, M.S.; Rambhau, D.K. Development and validation for the simultaneous estimation in of metformin and empagliflozin in drug product by RP-HPLC. European J. Biomed. Pharma. Sci., 2018, 5(2), 404-410.
47. Adaway JE, Keevil BG. Therapeutic drug monitoring and LC MS/MS. Journal of Chromatography B. 2022 Feb 1;883:33-49.
48. Thallapalli, A.K.G.; Manda, R.M. Development and validation of empagliflozin and linagliptin simultaneous estimation in rat plasma using freezing lipid precipitation and SCX-SPE assisted HPLC MS/MS method and its application in pharmacokinetic studies. Anal. Sci., 2024, 40(1), 185-198.
49. Vijaya, V.; Ujjwala, K.; Pallavi, D.; Choudhari, V.P. Development of validated RP-HPLC method for estimation of empagliflozin and metformin in combined formulation. J. Pharm. Res. Int., 2021, 33(60A), 1-7.
50. Epshtein, N., Sevast’yanova, V. & Koroleva, A. Validation of Related-Substances determination methods for detecting unidentified substances (A Review). Pharm. Chem. J.2020; 54, 959–967.
51. Rohde g, Lowen S, R. Determination of finerenone Anovel, selective non-steroidal receptor antagonist- in human plasma by HPLC tandem mass spectrometry and its application to pharmacokinetics study in plasma, J Chromatogr. B Analyst technol biomed life sci 2021, May 153.
52. Adaway JE, Keevil BG. Therapeutic drug monitoring and LC-MS/MS. Journal of chromatography B.;2022 feb 1;883:33-49.
53. Metkari, V. B. Mrs. Vanita Gade. method development and validation of finerenone by RP-HPLC method. Int. J. Innovative Res. Technol. 2024;11, 751–761.
54. Finotti Cordeiro, C., Franco, L., Teixeira Carvalho, L. & Bonfilio, R. D. Impurities in active pharmaceutical ingredients and drug products: A critical review. Anal. Chemistry, 2024, 1–21.
55. Locatelli, M. et al. green profile tools: Current status and future perspectives. Adv. Sample Preparation. 2023; 6-16
56. Ayoub, B.M.; Mowaka, S.; Elzanfaly, E.S.; Ashoush, N.; Elmazar, M.M.; Mousa, S.A. Pharmacokinetic evaluation of empagliflozin in healthy Egyptian volunteers using LC-MS/MS and comparison with other ethnic populations. Sci. Rep., 2017, 7(1), 2583.
57. International conference on harmonization, ICH guidelines, Validation of analytical procedures technical requirements for registration of pharmaceuticals for human Use: Text and Methodology Q2 (R1), international conference on Harmonization, Geneva, Swizerland.2005.
58. Plotkar Wasylak J. & Wojnowski, W. Complementary green analytical procedure index (Complex GAPI) and software. Green Chem.2021 23, 8657–8665.
59. Teasdale, A., Elder, D., Harvey, J. & Spanhaak, S. Impurities in new drug substances and new drug products: ICH Q3A/B: key guidelines in the general impurity management process. ICH Qual. Guidelines: Implement. Guide, 2017;6, 167–198.
60. Kraus Bj, Weir MR, Bakri's GL et al. Characterization and implications of the initial estimated glomerular filtration rate dip upon sodium-glucose contransporter-2inhibiton with empagliflozin in the EMPA-REG OUTCOME. Trial. Kidney int. 2021; 99:750-62.
61. Agarwal R, Tu W, Farjat AE et al. Impact of finerenone- induced albuminuria reduction on chronic kidney disease out- comes in type 2 diabetes: a mediation analysis. Ann Intern Med 2023; 176 :1606–16.
62. Stachteas P, Nasoufidou A, Patoulias D, et al. The role of sodium-glucose Co-transporter-2 inhibitors on diuretic resistance in heart failure. Int J Mol Sci. 2024;25(6):3122
63. Badve SV, Bilal A, Lee MMY, et al. Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomized controlled trials. Lancet Diabetes Endocrinol. 2025;13 (1):15–28.
Article Sidebar
Published
Aug 20, 2025
Article Details
How to Cite
Nidhi Nagani, Dr. Neha Tiwari, & Dr. Pragnesh Patani. (2025). A SYSTEMATIC REVIEW ON ANALYTICAL METHOD FOR THE ESTIMATION OF FINERENONE AND EMPAGLIFLOZIN. Journal of Population Therapeutics and Clinical Pharmacology, 32(7), 1862-1872. https://doi.org/10.53555/8bm7e296
Section
Articles
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Author Biographies
Nidhi Nagani
Khyati College of Pharmacy, Ahmedabad, Gujarat, India.
Dr. Neha Tiwari
Department of Pharmaceutical Chemistry, Khyati College of Pharmacy, Gujarat Technological University, Ahmedabad, Gujarat, India.
Dr. Pragnesh Patani
Department of Pharmacology, Khyati College of Pharmacy, Gujarat Technological University, Ahmedabad, Gujarat, India.
How to Cite
Nidhi Nagani, Dr. Neha Tiwari, & Dr. Pragnesh Patani. (2025). A SYSTEMATIC REVIEW ON ANALYTICAL METHOD FOR THE ESTIMATION OF FINERENONE AND EMPAGLIFLOZIN. Journal of Population Therapeutics and Clinical Pharmacology, 32(7), 1862-1872. https://doi.org/10.53555/8bm7e296