Abdrhman Mahmoud Gamil
Abstract: There is no pharmacopoeial specific monograph for chemical analysis of empagliflozin. HPLC method had been developed inhouse. A column C-18, Thermo-scientific Hypersil 4.6 mm × 150 mm of 5 µm pores was used. The detector is UV detector at 224 nm. The flow rate is 1ml/min for injection volume of 20 µL at 30 ͦC and run time is 10 minutes. The mobile phase is Orthophosphoric acid buffer and Acetonitrile 70: 30. The method was then validated for system suitability, specifity, accuracy, range linearity, the system precision; repeatability, and robustness by changing the flow rate wavelength and speed of the paddle. All the results were compared with the USP acceptable criteria for each test and were found to satisfactory. The method stands validated and can be used for routine quality control and stability studies.
Keywords: Empagliflozin method of Analysis, Empagliflozin method validation, in-house dissolution method validation, method validation procedure