Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 5 Issue 12

Forced Degradation Studies for Estimation of Finerenone by RP-HPLC Method

Arulselvan Murugesan1* and Annapurna Mukthinuthalapati Mathrusri2

1Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, India
2Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

*Corresponding Author: Arulselvan Murugesan, Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, India.

Received: September 21, 2021; Published: November 12, 2021

Abstract

Finerenone is a mineralocorticoid receptor antagonist approved by USFDA for the treatment of chronic kidney diseases (CKD) progression in Type 2 Diabetic Mellitus (T2DM) patients. It reduces the sustained risk of GFR and other risks associated with T2DM. This work involved developing first of its kind simple, precise and stability indicating method for analyzing Finerenone by RP-HPLC. The assay was carried out in HPLC X-bridge C18 Column, 150 mm x 4.6 mm, 3.5 µm, using mobile phase Acetonitrile and Ortho-Phosphoric acid (70:30% v/v) at a flow rate of 1 mL/min. The analyte was detected by using UV detector at a wavelength of 225 nm. The proposed method validation as per ICH guidelines and showed that the proposed method is highly sensitive, accurate, precise, robust, linear and stability indicating. The linear regression value was found to be greater than 0.9999 with Y= 261640x+32993 and r2 = 0.9999 with the concentration range of 1 µg/mL to 50 µg/mL. Good amount of recovery (100.3%, 100.4 and 100.6%) acceptable closeness of agreement (0.74 and 0.11) observed for Recovery and Intermediate and Method Precision studies conducted by this developed method. Stress degradation study reveals notable degradation within the official guideline values provided by ICH.

Keywords: Chronic Kidney Disease; Finerenone; T2DM; Mineralocorticoid; GFR

References

  1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215341s000lbl.pdf
  2. Peter Kolkhof and Lars Barfacker. “Mineralocorticoid receptors: 60 years of research and development”. Journal of Endocrinology 234 (2017): T125-140.
  3. Juan Simon Rico-Mesa., et al. “Mineralocorticoid Receptor Antagonists: A Comprehensive Review of Finerenone”. Current Cardiology Reports 22 (2020): 140.
  4. Kolkhof P., et al. “Nonsteroidal antagonists of the mineralocorticoid receptor”. Current opinion in Nephrology and Hypertension5 (2015): 417-424.
  5. Kolkhof P., et al. “Finerenone, a novel selective non-steroidal mineralocorticoid receptor antagonist protects from rat cardio renal injury”. Journal of Cardiovascular Pharmacology (2014).
  6. Gabriele Rohde., et al. “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”. Journal of Chromatography B 1172 (2021): 122643.
  7. “HPLC calibration process parameters in terms of system suitability test”. Austin Chromatography 1.2 (2014).
  8. USP - The United States Pharmacopeia and National Formulary USP 42 NF37, The United States Pharmacopoeial Convention, Inc.: Rockville, MD (2019).
  9. ICH - International Council of Harmonization. “Stability testing of New Drug Substances and Products - Q1A (R2)” (2003).
  10. ICH Harmonised Tripartite Guideline, Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B, 1996 (2020).
  11. ICH Harmonised Tripartite Guideline Validation of analytical procedures: text and methodology Q2 (R1), in: Validation of Compendia Procedures USP 40 - NF 35, (Chapter 1225) (2005): 1780-1783.

Citation

Citation: Arulselvan Murugesan and Annapurna Mukthinuthalapati Mathrusri. “Forced Degradation Studies for Estimation of Finerenone by RP-HPLC Method". Acta Scientific Pharmaceutical Sciences 5.12 (2020): 25-31.

Copyright

Copyright: © 2020 Arulselvan Murugesan and Annapurna Mukthinuthalapati Mathrusri. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is July 10, 2024.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of "Best Article of the Issue"
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.

Contact US