A Simple and Sensitive Method for Determination of Glimepiride in Human Serum by HPLC

Abstract A simple and sensitive high performance liquid chromatographic (HPLC) method for glimepiride determination in human serum is described. The assay involves one‐step liquid‐liquid extraction with dichloromethane in acidified serum. Glibenclamide is used as the internal standard. Detection is done at 228 nm and limit of quantification is less than 10 ng/mL for glimepiride. The calibration curves are linear over the concentration range tested (10–1000 ng/mL). Accuracy, precision, and stability studies are performed. This method is applied to the analysis of glimepiride serum samples of 41 Lebanese male volunteers after oral administration of a single glimepiride 3 mg tablet. Pharmacokinetic analysis of the data is done using a noncompartmental approach with WinNonlin software (WinNonlin® Professional, version 4.1).