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A simple, fast and economic reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous and quantitative analysis of Finerenone and Empaglifozin in laboratory prepared tablets. The method was developed using the mobile phase comprising of methanol, water and trifluoroacetic acid in the ratio of 68:32:0.05 (v/v) over C-18 hypersil column (250 x 4.6 mm, 5 um) at ambient temperature. The flow rate was at 1.0 ml/min and the eluent was monitored by UV detection at 245 nm. The retention times for the nephroprotective drugs- Finerenone & Empagliflozin were found to be 3.2 and 4.6 minutes, respectively, with good resolution and symmetric peaks. The recoveries were found to be >99% for both Finerenone and Empaglifozin, demonstrative of accuracy of the protocol. Inter-day and intra-day precision of the new method were less than the maximum allowable limit (RSD%˃2.0) according to ICH, USP and FDA guidelines. The method showed linear response with correlation coefficient (r2) values of 0.99999 for finerenone and 0.99995 for empagliflozin. The LOD & LOQ of finerenone and empagliflozin were found to be 0.03 ug/ml, 0.09 ug/ml & 0.27 ug/ml, 0.81 ug/ml respectively. Therefore, the method was found to be accurate, reproducible, sensitive and less time consuming and can be successfully applied for the assay of finerenone and empagliflozin in combined formulations.
"Analytical Method Development and Validation for simultaneous estimation of Finerenone and Empagliflozin by RP-HPLC in prepared tablets", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 5, page no.c809-c818, May-2025, Available :http://www.ijrti.org/papers/IJRTI2505294.pdf
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2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator