ABSTRACT

The World Health Organization (WHO) reports that 10% of the medications in Low and Middle Income Countries (LMICs) are of low quality, which presents a serious risk to public health. The development and application of quick, affordable, and effective analytical techniques is one way to get around this issue. A new non-steroidal mineralocorticoid receptor antagonist called Finerenone has demonstrated encouraging reno protective and cardiac effects in Chronic Kidney Disease (CKD). A new, simple and quick HPTLC technique was developed and verified for quantitative estimation of Finerenone using densitometry detection at 235 nm. Finerenone was chromatographed on silica gel 60 F254 precoated TLC plates using chloroform, ethyl acetate, methanol, and 1% aqueous ammonia were combined in the mobile phase at the following ratios: 5:3.5:1.5:0.5 (v/v/v/v). The linear regression analysis data for calibration plots showed good linear relationship with r2= 0.999 in the concentration range 400-1400 ng/band. The method was found to give compact band for the drug (Rf is 0.47 ± 0.01). The range of recoveries was 98% to 102%. For Finerenone, the limits of detection and quantitation were 65.6 and 198.7 ng/spot, respectively. In compliance with ICH requirements, the developed approach was validated. Statistical analysis of the data showed that the method is precise,accurate, reproducible and selective for the analysis of Finerenone. The method was successfully used for the estimation of Finerenone as a bulk drug and in commercially available formulation. Keywords: Finerenone, chronic kidney diseases, analytical method development, high performance thin layer chromatography (HPTLC), Validation
Publication date: 01/06/2025

https://ijbpas.com/pdf/2025/June/MS_IJBPAS_2025_9121.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.6.9121