Reverse Phase High Performance Liquid Chromatographic Method for Separation and Estimation of impurities present in Pharmaceutical Formulation of Empaglifozin

Abstract

Empaglifozin is a Sodium-glucose co-transporter-2 inhibitors work by inhibiting SGLT2, to prevent reabsorption of glucose and facilitate its excretion in urine. Impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulation. A simple and very sensitive method developed for estimation of impurities present in Empaglifozin formulation by Reverse Phase High Performance Liquid Chromatographic method. Method is capable to detect impurities in very low level (1µg/mL). Chromatographic separation of six different impurities was achieved on Inertsil ODS-2 (250 x 4.6) mm, 3µm column using gradient elution method at 30°C column temperature and the detection was carried at 230nm at a flow rate of 1.0 mL/min. The method was validated as per ICH Q2(R1) guideline along with stress studies.