Development and Validation of a New Analytical Rp-HPLC Method for the Quantitative Estimation of Finerenone in Api Form and Marketed Pharmaceutical Dosage Form
Corresponding Author(s) : Gade Sammaiah
bhargavsynpharma@gmail.com
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 2 (2023): 2023 Volume -11 - Issue 2
Abstract
A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Finerenone in bulk form and marketed formulation. Separation of Finerenone was successfully achieved on a Symmetry ODS C18 (4.6 x 250mm, 5?m) column in an isocratic mode of separation utilizing Acetonitrile: Methanol in the ratio of 80:20% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 272nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 10-50mcg/mL for Finerenone. The correlation coefficient was found to be 0.999 for Finerenone. The LOD and LOQ for Finerenone were found to be 1.1µg/mL and 3.2µg/mL respectively. The proposed method was found to be good percentage recovery for Finerenone, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.
Keywords
Finerenone
RP-HPLC
Accuracy
ICH Guidelines
1.
Jyothi Mirjapuram, Gade Sammaiah. Development and Validation of a New Analytical Rp-HPLC Method for the Quantitative Estimation of Finerenone in Api Form and Marketed Pharmaceutical Dosage Form. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2023 Jun. 27 [cited 2026 Apr. 12];11(2):210-8. Available from: https://ijamscr.com/ijamscr/article/view/1331
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References
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References
1. Available from: https://go.drugbank.com/drugs/DB16165.
2. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Finerenone.
3. Available from: https://en.wikipedia.org/wiki/Finerenone. Wikipedia.
4. Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry. 23rd ed.Goel publishing house Meerut; 2004. p. 12-23.
5. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis. 7th ed, CBS publishers and distributors. New Delhi; 1986. p. 518-21, 580-610.
6. Adamovies J. Chromatographic analysis of pharmaceutical. 2nd ed. New York: Marcel Dekker, Inc. p. 74, 5-15.
7. Chatwal G, Anand SK. Instrumental methods of chemical analysis. 5th ed. New Delhi: Himalaya publishing house; 2002. p. 1.1-8, 2.566-70.
8. Skoog DA, Holler J, Nieman TA. Principle of instrumental analysis. 5th ed, Saunders college publishing; 1998. p. 778-87.
9. Skoog, Holler, Nieman. Principals of instrumental analysis. 5th ed, Harcourt Publisher’s international company; 2001. p. 543-54.
10. Kemp W. Organic spectroscopy. New York: Palgrave; 2005. p. 7-10, 328-30.
11. Sethi PD. HPLC: quantitative analysis pharmaceutical formulations, CBS publishers and distributors. New Delhi, India; 2001. p. 3-137.
12. Michael E, Schartz IS, Krull. Analytical method development and validation; 2004. p. 25-46.
13. Snyder R, Kirkland J, Glajch L. Practical HPLC method development. 2nd ed, a Wiley international publication; 1997. p. 235, 266-8, 351-353.653-600.686-695.
14. Basic education in analytical chemistry. Anal Sci. 2001;17(1).
15. Method validation guidelines international conference on harmonization; GENEVA; 1996.
16. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New Work. 1993;57:411-28.
17. Moffat AC, Osselton MD, Widdop B. Clarke’s analysis of drugs and poisons. Vol. 2004. London: Pharmaceutical press; 1601-1602. p. 1109-10.
18. Florey K. Analysis profile of drugs substances. New York: Academic press; 2005. p. 406-35.
19. Arora PN, Malhan PK. Biostatistics, Himalaya Publishers house. India. p. 113, 139-40, 154.
20. Snyder LR, Kirkland JJ, Dolan JW. Introduction to modern liquid chromatography. New York: John Wiley & Sons; 2009.
21. Dong MW. Modern HPLC for practicing scientists. Wiley; 2006.
22. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. New York: John Wiley & Sons; 1997.
23. Ahuja S, Rasmussen HT, editors. HPLC method development for pharmaceuticals. Academic Press; 2007.
24. Ahuja S, Dong MW, editors. Handbook of pharmaceutical analysis by HPLC. Elsevier/Academic Press; 2005.
25. Kazakevich YV, R. HPLC for pharmaceutical scientists LoBrutto, editor. Wiley; 2007.
26. Neue UD. HPLC columns: theory, technology, and practice. New York: Wiley-VCH Press; 1997.
27. McMaster MC. HPLC, a practical user’s guide. Wiley; 2007.
28. Doserge, Wilson and Gisvold’s textbook of organic medicinal and pharmaceutical chemistry. 8th ed. Lippincott Company; 1982. p. 183-97.
29. Snyder LR, Dolan JW. High-performance gradient elution: the practical application of the linear-solvent-strength model. Wiley Interscience; 2006.
30. Giddings JC. Dynamics of chromatography, Part I. Principles and theory. New York: Marcel Dekker, Inc; 1965. p. 281.
31. Robards K. Principles and practice of modern chromatographic methods. Haddad, P.R., Jackson, P.E. Amsterdam. Elsevier/Academic Press; 1994.
32. ICH. Guidance. Validation of analytical methods – definition and terminology. Q2A. Geneva: international Conference on Harmonization. Nov 2005.
33. ICH Guidance, Validation of analytical procedures – methodology. Q2B. Geneva: international Conference on Harmonization. Nov 2005.
34. Murugesan A, Mathrusri AM. Forced degradation studies for estimation of finerenone by RP-HPLC method. Acta Sci Pharm Sci. 2021;5(12, Dec):25-31. doi: 10.31080/ASPS.2021.05.0818 (ISSN: 2581-5423).
35. 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 Analyt Technol Biomed Life Sci. 2021, May 15;1172:122643. doi: 10.1016/j.jchromb.2021.122643. PMID 33770684.
2. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Finerenone.
3. Available from: https://en.wikipedia.org/wiki/Finerenone. Wikipedia.
4. Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry. 23rd ed.Goel publishing house Meerut; 2004. p. 12-23.
5. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis. 7th ed, CBS publishers and distributors. New Delhi; 1986. p. 518-21, 580-610.
6. Adamovies J. Chromatographic analysis of pharmaceutical. 2nd ed. New York: Marcel Dekker, Inc. p. 74, 5-15.
7. Chatwal G, Anand SK. Instrumental methods of chemical analysis. 5th ed. New Delhi: Himalaya publishing house; 2002. p. 1.1-8, 2.566-70.
8. Skoog DA, Holler J, Nieman TA. Principle of instrumental analysis. 5th ed, Saunders college publishing; 1998. p. 778-87.
9. Skoog, Holler, Nieman. Principals of instrumental analysis. 5th ed, Harcourt Publisher’s international company; 2001. p. 543-54.
10. Kemp W. Organic spectroscopy. New York: Palgrave; 2005. p. 7-10, 328-30.
11. Sethi PD. HPLC: quantitative analysis pharmaceutical formulations, CBS publishers and distributors. New Delhi, India; 2001. p. 3-137.
12. Michael E, Schartz IS, Krull. Analytical method development and validation; 2004. p. 25-46.
13. Snyder R, Kirkland J, Glajch L. Practical HPLC method development. 2nd ed, a Wiley international publication; 1997. p. 235, 266-8, 351-353.653-600.686-695.
14. Basic education in analytical chemistry. Anal Sci. 2001;17(1).
15. Method validation guidelines international conference on harmonization; GENEVA; 1996.
16. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New Work. 1993;57:411-28.
17. Moffat AC, Osselton MD, Widdop B. Clarke’s analysis of drugs and poisons. Vol. 2004. London: Pharmaceutical press; 1601-1602. p. 1109-10.
18. Florey K. Analysis profile of drugs substances. New York: Academic press; 2005. p. 406-35.
19. Arora PN, Malhan PK. Biostatistics, Himalaya Publishers house. India. p. 113, 139-40, 154.
20. Snyder LR, Kirkland JJ, Dolan JW. Introduction to modern liquid chromatography. New York: John Wiley & Sons; 2009.
21. Dong MW. Modern HPLC for practicing scientists. Wiley; 2006.
22. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. New York: John Wiley & Sons; 1997.
23. Ahuja S, Rasmussen HT, editors. HPLC method development for pharmaceuticals. Academic Press; 2007.
24. Ahuja S, Dong MW, editors. Handbook of pharmaceutical analysis by HPLC. Elsevier/Academic Press; 2005.
25. Kazakevich YV, R. HPLC for pharmaceutical scientists LoBrutto, editor. Wiley; 2007.
26. Neue UD. HPLC columns: theory, technology, and practice. New York: Wiley-VCH Press; 1997.
27. McMaster MC. HPLC, a practical user’s guide. Wiley; 2007.
28. Doserge, Wilson and Gisvold’s textbook of organic medicinal and pharmaceutical chemistry. 8th ed. Lippincott Company; 1982. p. 183-97.
29. Snyder LR, Dolan JW. High-performance gradient elution: the practical application of the linear-solvent-strength model. Wiley Interscience; 2006.
30. Giddings JC. Dynamics of chromatography, Part I. Principles and theory. New York: Marcel Dekker, Inc; 1965. p. 281.
31. Robards K. Principles and practice of modern chromatographic methods. Haddad, P.R., Jackson, P.E. Amsterdam. Elsevier/Academic Press; 1994.
32. ICH. Guidance. Validation of analytical methods – definition and terminology. Q2A. Geneva: international Conference on Harmonization. Nov 2005.
33. ICH Guidance, Validation of analytical procedures – methodology. Q2B. Geneva: international Conference on Harmonization. Nov 2005.
34. Murugesan A, Mathrusri AM. Forced degradation studies for estimation of finerenone by RP-HPLC method. Acta Sci Pharm Sci. 2021;5(12, Dec):25-31. doi: 10.31080/ASPS.2021.05.0818 (ISSN: 2581-5423).
35. 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 Analyt Technol Biomed Life Sci. 2021, May 15;1172:122643. doi: 10.1016/j.jchromb.2021.122643. PMID 33770684.