Analytical Method Development and Validation of Glimepiride in Tablet Dosage Form by New RP-HPLC

Abstract

A simple, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative estimation of Glimepiride in tablet dosage form. Chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 µm) with an isocratic mobile phase consisting of Acetonitrile: Phosphate Buffer (pH 3.0) in the ratio of 60:40 (v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 230 nm using a UV/PDA detector. Under optimized chromatographic conditions, Glimepiride showed a sharp and symmetrical peak with a retention time of approximately 5.8 minutes.

The developed method was validated according to ICH Q2(R1) guidelines for parameters such as system suitability, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method exhibited excellent linearity in the concentration range of 10–60 µg/mL with a correlation coefficient (r² = 0.9994). The %RSD values obtained for intraday and interday precision studies were 0.48% and 0.62%, respectively, indicating good repeatability and reproducibility of the method. Accuracy studies performed by recovery method at 80%, 100%, and 120% levels showed mean recovery of 99.73%, confirming the reliability of the developed method. The calculated LOD and LOQ values were found to be 0.85 µg/mL and 2.58 µg/mL, respectively, demonstrating good sensitivity of the method. Robustness studies revealed that small deliberate changes in chromatographic conditions such as flow rate and wavelength did not significantly affect analytical performance.

The developed RP-HPLC method was found to be simple, rapid, precise, accurate, economical, and suitable for routine quantitative analysis of Glimepiride in bulk drug and marketed tablet dosage forms. The method can also be effectively applied for quality control analysis and stability studies in pharmaceutical industries.

Keywords: Glimepiride, RP-HPLC, Method validation, Stability-indicating method, Tablet dosage form, ICH guidelines