HPLC Method Development for the Estimation of Empagliflozin in Bulk and Pharmaceutical Formulation

Abstract

An efficient and simple HPLC method has been developed and validated for the determination of Empagliflozin in marketed formulations. The mobile phase used for the chromatographic runs consisted of Water:ACN (55:45 v/v). The separation was achieved on a Symmetry, Waters C-18, 100 x 4.6 mm, 2.7 um, Poroshell 120 EC-C18, using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 225 nm. The method was linear at the concentration range of 2–12 μg/ml for both the formulations. The method has been validated according to ICH guidelines concerning precision, accuracy, and forced degradation. Empagliflozin limit of detection (LOD) and limit of quantification (LOQ) were 0.005938 ng/ml and 0.017813 ng/ml respectively.