World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF A NEW ANALYTICAL RP-HPLC METHOD FOR THE ESTIMATION OF FINERENONE IN BULK AND MARKETED FORMULATION

Santhosh Illendula*, S. K. Samiha, A. Bheema Naik, Dr. CH. V. Suresh and Dr. K. N. V. Rao

ABSTRACT

A novel, simple, accurate, precise, sensitive and specific analytical RP-HPLC method was developed and validated
for the quantitative estimation of Finerenone in bulk drug and marketed pharmaceutical dosage form. The
Chromatographic separation was achieved on an Symmetry ODS C18 (4.6×250mm, 5μm) analytical column using
mobile phase composition of methanol and Phosphate Buffer in ratio of (35: 65% v/v) that was set at a flow rate of
1.0μl/min with detection of 235 nm. The retention time of Finerenone was found to be 3.006min. The drug was
analyzed by following the guidelines of International conference on Harmonization (ICH). This drug showing
linearity in the concentration range of 6-14μg/ml and the correlation coefficient showing R2 = 0.9996. The %
Recoveries showing within the limits. The presentation of the method was validated according to the present ICH
guidelines for accuracy, precision and robustness, Linearity, limit of quantification, limit of detection linearity.

[Full Text Article]   [Download Certificate]