Development and Validation of an RP-HPLC Method for the Estimation of Glimepiride in Compliance with Quality Assurance Standards
Year: 2025
Type: article
Abstract: 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.
Author: Vaishnavi Verma, Dr. Nimita Manocha*, Gyanendra Patel, Dr. Ritesh Patel
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7078700514
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