Validation d'une méthode de dosage d'une combinaison fixe de glimépiride et metformine par chromatographie liquide haute performance (HPLC)

Abstract: The combination of metformin and glimepiride in tablet form is used to treat type 2 diabetes. At present, no method for identifying or essaying this combination is described in the pharmacopoeia. The aim of this study was to develop and validate a rapid and simple method for identifying and assaying the two active ingredients using high-performance liquid chromatography (HPLC). The gradient mode was used with two solutions A and B. Solution A was a buffer (pH=4.0) and solution B was a solution of tetrahydrofuran diluted with methanol. A L1 column (C18; 12.5 cm x 4.6 mm; 5µm, 25°C) was used with an elution flow rate of 1 ml/min, an injection volume of 10µl and detection was carried out at 230nm (UV). The diluent consisted of methanol (80%), acetonitrile (10%) and water (10%). The validation results showed good specificity, good linearity (R2 >0.995), good repeatability and intermediate precision (coefficient of variation < 5%) and good accuracy (recovery rate between 98% and 102%). The method is valid and can be used routinely for drug quality control. Keywords: Diabetes, Medicines, quality control, identity, assay.