Stability Indicating Assay Method of Metformin, Linagliptin and Empagliflozinin Pharmaceutical Dosage Form by HPLC Method

Document Type : Review Articles


1 chemistry, science, Banha university

2 Department of Chemistry, Faculty of Science, Zagazig University, Zagazig 44519, Egypt


A new reversed phase high performance liquid chromatographic method for simultaneous determination of Metformin HCl, Linagliptin and Empagliflozin has been developed and validated to be a simple, sensitive, rapid, specific, precise, and accurate method. Chromatographic separation achieved on C18 column (4.6-mm x 25-cm; 5-µm) Thermo hypersil. through isocratic elution using Water: Acetonitrile in ratio (65:35 v/v) adjusted to pH 3.5 with Orthophosphoric acid as a mobile phase at flow rate of 1.0 ml/min. UV detection was operated at 269 nm and injection volume was 10μl. Linearity ranges for Metformin HCl, Linagliptin and Empagliflozin were 10000-30000, 50-150 and 250-750 μg/ml, respectively. The proposed method showed good linearity, accuracy, precision and was successfully applied for determination of the three drugs in laboratory prepared mixtures. The method described proved its validity for routine analysis of the drugs under study in pharmaceutical preparations.