Development and validation of RP-HPLC method for glimepiride and its application for a novel self-nanoemulsifying powder (SNEP) formulation analysis and dissolution study

Abstract

Background: There are many analytical methods available for estimation of glimepiride in biological samples and pharmaceutical preparations. To our knowledge, there is no specific reverse-phase high-performance liquid chromatography (RP-HPLC) method for estimation of glimepiride and its dissolution study in self-nanoemulsifying powder (SNEP) formulation. Methods: A simple method was carried out on a 5-μm particle octadesyl silane (ODS) column (250 × 4.6 mm) with acetonitrile: 0.2 M phosphate buffer (pH = 7.4) 40:60 v/v as a mobile phase at a flow rate of 1 mL/min, and quantification was achieved at 228 nm using PDA detector. Results: The correlation coefficient (r2) was found to be 0.999 over the concentration range of 0.2 to 2 μg/mL for glimepiride. The method was validated for linearity, accuracy, and precision. The limit of detection and limit of quantification were found to be 0.38 and 1.17 μg/mL, respectively. Conclusions: The proposed method was found to be simple, precise, suitable, and accurate for quantification of glimepiride as an alternative to the existing methods for the routine analysis of glimepiride in pharmaceutical formulations and in vitro dissolution studies.