Stability Indicating Assay of Empagliflozin and Linagliptin

Abstract

The newly developed stability‐indicating RP-HPLC method is simple, robust, and validated on the basis of ICH guidelines for simultaneous determination of Empagliflozin and Linagliptin in tablets. Retention times under the optimized condition were 1.86 and 2.61 minutes for Empagliflozin and Linagliptin, respectively. This research article indicates the best separation of Empagliflozin and Linagliptin from their degradation products. Separation was achieved on a Sunniest ECO C₁₈, 250 mm x 4.6 mm, 5 µm analytical column at a wavelength of 275nm, using a mobile phase: phosphate buffer (pH-5) and methanol (20:80) in an isocratic elution mode at a flow rate of 1.5 ml/min, an injection volume of 10 µl, and a run time of 4 minutes. The RSDs for the precision studies were 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 out using 0.1N HCl, 0.1N NaOH, 3% H₂O₂ and exposure to temperature (60⁰ C). Stress study indicates the Empagliflozin is completely degraded in an oxidative medium and 39.22% for Linagliptin. The degradation of the drugs in acidic medium and exposure to temperature are within the ICH acceptable limits. The two API chromatographic peaks in basic degradation study are not well resolved. The observed students ‘t’ test values are within the acceptable range in the tablet assay and recovery study. So this method is a fast, sensitive, robust, and efficient high-performance liquid chromatographic method for the concurrent determination of Empagliflozin and Linagliptin