International Journal of Drug Delivery Technology
Volume 14, Issue 2

Development of a Robust and Reliable RP-HPLC Method for the Estimation of Finerenone in Tablet Dosage Form

Sumalatha Chepyala1,2, Srinivas Medidi1*, Jitender Kumar Malik2

1Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Medchal, Hyderabad, India.

2School of Pharmacy, OPJS University, Churu, Rajasthan, India. 

Received: 25th January, 2024; Revised: 10th March, 2024; Accepted: 08th May, 2024; Available Online: 25th June, 2024 

ABSTRACT

An advanced analytical method was explored, specifically tailored for estimating finerenone, a vital drug found in tablet formulations intended to reduce the risk of chronic kidney disease in patients with type-2 diabetes. This sophisticated technique employs an Inertsil ODS 3V C18 column (5 μm particle size x 250 x 4.6 mm) for precise separation of analyte. The mobile phase consists of an ammonium dihydrogen phosphate buffer (pH 4.5) and acetonitrile (60:40), which is a carefully balanced mixture that flows consistently at 1.0 mL/min. UV detection is achieved at a wavelength of 238 nm. Finerenone’s characteristics are unveiled with a brief retention time of 4.06 minutes, highlighting the efficiency of the method. The method demonstrates linearity within the concentration range of 2.5 to 15 μg/mL, offering a comprehensive scope for accurate analysis. This robust reversed-phase high-performance liquid chromatography (RP-HPLC) method undergoes thorough validation following International Council for Harmonisation (ICH) guidelines, ensuring its reliability. Notably, the accuracy is impressive, with a mean recovery falling comfortably within the acceptable range of 99.76 to 101.09%. In summary, our analytical approach stands out for its simplicity, precision, sensitivity, rapidity, and robustness in estimating finerenone in tablet formulations.

Keywords: Finerenone, RP-HPLC, Method development, Validation.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.2.15

How to cite this article: Chepyala S, Medidi S, Malik JK. Development of a Robust and Reliable RP-HPLC Method for the Estimation of Finerenone in Tablet Dosage Form. International Journal of Drug Delivery Technology. 2024;14(2):703-708.

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