Abstract: A novel, simple rapid reverse phase high performance chromatography (RPHPLC) method has been developed and validated for the determination of Linagliptin and Empagliflozine in tablet dosage form. Isocratic chromatography has been developed on a ODS column (250 x 4.6mm, 5µ) with a mobile phase consists of buffer and Acetonitrile (45:50) with the flow rate of 1ml/min with PDA detector at 245 nm. The total run time was 7 minutes. The retention time for Lingaliptin and Empagliflozine were found to be 2.2 and 3.6 min respectively. Chromatography parameters were validated as per ICH guidelines and can be applied for routine quantitative analysis of drugs in combined tablet dosage form.
Keywords: ICH, Validation, Empagliflozine, Linagliftin.