Greenness analysis of stability indicating RP-HPLC method for determination of lobeglitazone sulphate and glimepiride in tablets

Abstract

The present study focuses on the development and validation of a stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of lobeglitazone sulfate (LBG) and glimepiride (GLM) in tablet dosage forms. The separation was achieved using an Inertsil C18 column (150 × 4.6 mm, 5 μm) using mobile phase consisting of potassium dihydrogen phosphate buffer (pH 2.3): methanol (27:73, v/v) at a flow rate of 1.2 mL/min. The column oven temperature was maintained at 35 °C and UV detection was performed at 228 nm. LBG and GLM were eluted with mean retention time of 2.057 min and 7.489 min, respectively. The method demonstrated linearity in the range of 2.50–7.50 µg/mL for LBG and 5–15 µg/mL for GLM. The stability-indicating nature of the method was confirmed through forced degradation studies under acidic, basic, oxidative, thermal, and photolytic conditions. The method was validated in accordance with ICH Q2(R2) guidelines. The greenness of the proposed method using GAPI, AGREE, BAGI, and AGREEprep tools indicated compliance with principles of green analytical chemistry.