Abstract

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF SELECTED CARDIOVASCULAR DRUG FINERENONE BY DIFFERENT ANALYTICAL TECHNIQUES

Dr. Santhosh Illendula*, Vusala Tejaswi, Varipally Sai Sindhu, Vootkuri Nihathi, Jetamoni Mahesh, Kurumeti Divya, Mothe Praneeth, Dr. Suthakaran Raj

Abstract

Instrumental methods of analysis are analytical techniques that use scientific instruments to identify, separate, and quantify chemical substances in pharmaceutical formulations. These methods provide rapid, accurate, sensitive, and precise analysis compared with conventional analytical techniques. Analytical method development involves optimization of parameters such as solvent selection, wavelength, mobile phase, flow rate, and chromatographic conditions to obtain accurate, precise, and reproducible results. The developed method is validated according to ICH guidelines for linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantification (LOQ). Finerenone acts by selectively blocking the mineralocorticoid receptor (MR) and thereby inhibits aldosterone-mediated inflammatory and fibrotic pathways in the kidney and cardiovascular system. It reduces renal inflammation, fibrosis, and cardiovascular risk associated with CKD and T2DM. Finerenone is primarily used to reduce the risk of kidney disease progression and cardiovascular events in appropriate patients with CKD associated with T2DM. Finerenone is indicated to reduce the risk of kidney disease progression and cardiovascular events.

Keywords: Finerenone, Instrumental analysis, Analytical method development, Method validation, Mineralocorticoid receptor antagonist, Accuracy, LOD, LOQ.