Method Development and Validation for Rapid Simultaneous Estimation of Empagliflozin and Linagliptin in Pharmaceutical Dosage form by Using RP-HPLC

S. Mohammed Yusuf*, Mulugeta Molla²
*Assistant Professor, Department of Pharmacy, College of Health Sciences, Debre Tabor University, Debre Tabor, Ethiopia.
²Head of the Department, Department of Pharmacy, College of Health Sciences, Debre Tabor University, Debre Tabor, Ethiopia.

ABSTRACT
A new method was established for simultaneous estimation of Empagliflozine and Linagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for these parathion of Empagliflozine and Linagliptin by using XterraC185µm (4.6*250mm) column, flow rate was1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wavelength was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module2695, PDA Detector 996, Empower-software version-2. The retention times were found to be 2.984mins and 3.525mins. The retention times were found to be 2.984mins and 3.525mins. The retention times were found to be 2.984mins and 3.525mins. The %purity of Empagliflozine and Linagliptin was found to be 100.7% and 101.4% respectively. The system suitability parameters for Empagliflozine and Linagliptin such as theoretical plates and tailing factor were found to be 1.0,3527 and 1.1,3115 the resolution was found to be 2.4. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)).  Hence the suggested RP-HPLC method can be used for routine analysis of Empagliflozine and Linagliptinin API and Pharmaceutical dosage form.
Keywords:Empagliflozine and Linagliptinin, RP-HPLC, XterraC185µm, Phosphate buffer