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
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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.




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