Development of a green-HPLC method for the analysis of empagliflozin and linagliptin as anti diabetic drugs in plasma samples

Abstract

Introduction: Linagliptin and empagliflozin are among the new drugs in the treatment regimen of type 2 diabetes. These drugs play a significant role in controlling blood sugar and reducing the long-term complications of diabetes. Linagliptin and empagliflozin are powerful drugs because their prescribed doses are low. Therefore, we need accurate methods to evaluate their blood concentration. In most of the previous researches that have been done to study these drugs, the effects of these processes on the environment have been ignored and a large amount of solvents or solvents that are dangerous have been used. Today, efforts are being made to develop analytical methods that, while having high accuracy, precision, sensitivity and speed, help to maintain human health and environmental standards.Objective: Development of an analytical method based on green HPLC to evaluate the plasma concentration of linagliptin and empagliflozin in human plasma samples.Method: To precipitate plasma proteins, acetonitrile was added to the plasma samples at a ratio of 1:1, and after centrifugation at 12000 rpm for 15 minutes, the clear supernatant was removed and injected into the system. The analysis of linagliptin and empagliflozin was performed simultaneously by LC-MS/MS device and with the isocratic flow of the mobile phase consisting of acetonitrile and 0.1 M acetic acid with a ratio of 35:65 at a speed of 0.6 ml/min. Results: The obtained results showed that the LOD and LOQ of LC-MS/MS method for linagliptin are 0.5787 and 1.7535 ng/ml and the LOD and LOQ of LC-MS/MS method for empagliflozin 3.8585 and 11.692 ng/ml respectively.Conclusion: Based on the obtained data and results, the developed method can be used to identify and measure linagliptin and empagliflozin drugs in clinical samples and pharmacokinetic studies.