Development and Validation of an RP-HPLC Method for the Estimation of Glimepiride in Compliance with Quality Assurance Standards

A simple, accurate, as well as precise Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed to estimate Glimepiride in pharmaceutical dosage forms with bulk. For optimization regarding retention time as well as peak characteristics, different columns, mobile phase ratios, and flow rates were used in various chromatographic trials. Optimal conditions were reached by an Xterra ODS C18 column (150 mm × 4.6 mm, 5 µm), using a mobile phase of Water: Acetonitrile (60:40 v/v) plus a flow rate of 0.8 mL/min. A sharp symmetric peak occurred, with a 2.9-minute retention time. The ICH guidelines validated the method in terms of specificity, accuracy, precision, and linearity. They also validated the method for system suitability. The technique is efficient, so it is suitable for routine quality control. It applies to Glimepiride as a bulk and formulation.