Stability Indicating Assay of Empaglifozin and Metformin

Abstract

The newly developed stability‐indicating RP-HPLC method is simple, robust and validated on the basis of ICH guidelines for the simultaneous determination of Empaglifozin and Metformin hydrochloride in the tablet. Retention times under the optimized condition were 2.104 and 4.0822min for Metformin and Empaglifozin respectively. This research article indicates best separation of Empaglifozin and Metformin from their degradation products. Separation was achieved on a Sunniest ECO C18, 250mm x 4.6mm, 5µm analytical column at wavelength of 225nm, using a mobile buffer (pH-1.8): acetonitrile (50:50) in an isocratic elution mode at a flow rate of 1.2ml/min, Injection volume: 10µl and run time 6mins. The %RSDs for the precision studies was less than 1.5% for both drugs. The %RSD was less than 1.5% in all the parameters of robustness. The forced degradation studies were carried by using 0.1N HCl, 0.1 N NaOH and % 3 H2O2 and there is only % 7.2 degradation in an acidic medium for emplaglifozin and 11.63% for Meformin where as there was nothing degradation in basic and oxidative method. The analyte peaks were clearly separated from the degradant peaks in forced degradation studies. So this method is a fast, sensitive, robust and efficient high performance liquid chromatographic method for the concurrent determination of Metformin and Empaglifozin in their combination, and thus this method can be effectively employed for routine quality control works.