Author(s): Abhijeet N. Raut *, Shailesh G. Jawarkar, Vaibhav S. Khodke, Vivek A. Khole
A very simple, accurate, precise, robust, rugged and stability indicating method with gradient elution was developed for simultaneous estimation of Empagliflozin and Linagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Empagliflozin and Linagliptin by using C18 (Equisil BDS) column (4.6 × 250 mm) 5μ, flow rate was 0.7 ml/min, mobile phase ratio was (40:60 v/v) methanol: water, detection wavelength was 224 nm and 294 nm. The instrument used was SHIMADZU-HPLC system, Pump -HPD 20A, Detector - UV detector, Software - UV Probe. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The Linearity study of Empagliflozin and Linagliptin was found in concentration range of 20 μg-40 μg, 60 μg, 80 μg, 100 μg and 10 μg, 20 μg, 30 μg, 40 μg, 50 μg correlation coefficient (r2) was found to be 0.988 and 0.991, % recovery was found to be 99.1% and 99.6.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.