Abstract

Objective: The aim of the research work is to develop and validate a novel, sensitive, specific, rapid, accurate, and precise, isocratic reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantitative determination of Empagliflozin drug substance in pure form and Marketed Pharmaceutical Dosage form. 
Methods: Liquid chromatographic method used for the analysis of the anti-Diabetic drug substance like Empagliflozin method was developed and validated by using efficient chromatographic separation method and was achieved with the use of HPLC WATERS with Empower2 Software with Isocratic with UV-Visible Detector. 
Results: The separation was achieved using Symmetry C18, 250 mm x 4.6 mm i.d.5µm particle size analytical column at ambient employing an isocratic elution. Empower software was used for data acquisition. During method validation all the parameters were evaluated as per ICH guidelines, which remained well within acceptable limits. 
Conclusion: The results of linearity, precision accuracy and specificity were proved to be within the limits. This method can be employed in routine analysis for estimation of Empagliflozin drug substance in quality formulations.