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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 Dapagliflozin and Desidustat in laboratory prepared tablets. The method was developed using the mobile phase comprising of methanol, water and trifluoroacetic acid in the ratio of 73:27:0.05 (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 228 nm. The retention times for the nephroprotective drugs- Dapagliflozin and Desidustat were found to be 3.9and 4.3 minutes, respectively, with good resolution and symmetric peaks. The recoveries were found to be >99% for both Dapagliflozin and Desidustat, 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 0.99988 for Dapagliflozin and 0.99995 for Desidustat. The LOD & LOQ of Dapagliflozin and Desidustat were found to be 0.16 ug/ml, 0.50 ug/ml & 0.55 ug/ml, 1.66 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 Dapagliflozin and Desidustat in combined formulations.
"Analytical method development and validation for simultaneous estimation of Dapagliflozin and Desidustat by RP-HPLC Method in prepared tablets", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 6, page no.b8-b15, June-2025, Available :http://www.ijrti.org/papers/IJRTI2506103.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