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A RP-HPLC method has been developed and validated for determination of Remogliflozin etabonate in bulk and pharmaceutical formulation. It was performed on Phenomenex Hyper clone column 5µm BDS C18-250 ×4.6 mm using Acetonitrile and water in the ratio of 80:20 as mobile phase at a flow rate of 1ml/min and analytes were monitored at 228 nm. The retention time for Remogliflozin etabonate was found to be 4.88 min. The peak obtained was symmetrical with tailing factor less than 1.5 and theoretical plates more than 2000. The developed method was validated in accordance to ICH guidelines and the results of all parameters was found to be within the acceptable limits. The linearity was found in the concentration range of 1-500μg/mL, LOD and LOQ was found to be 0.694 and 2.313μg/mL for Remogliflozin etabonate. The percentage Mean recovery at three different levels (80%, 100% and 120%) was found to be 100.71 %w/w and the % Assay for Remogliflozin etabonate in tablets was found to be 99.6 %w/w. The developed method has been found suitable for routine analysis of Remogliflozin etabonate in bulk and formulation (tablet).
Keywords:
Remogliflozin etabonate, RP-HPLC, ICH Guidelines
Cite Article:
"VALIDATED HPLC METHOD FOR ANALYSIS OF REMOGLIFLOZIN ETABONATE IN TABLETS", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 1, page no.a383-a390, January-2025, Available :http://www.ijrti.org/papers/IJRTI2501049.pdf
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ISSN:
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