“Development, validation and Greenness analysis of stability-indicating RP-HPLC method for simultaneous estimation of Lobeglitazone andGlimepiride in bulk and pharmaceutical formulation .”

Abstract

Diabetes mellitus is a long-term metabolic disorder that often requires combination therapy to achieve effective blood glucose control. In the present study, a simple, economical, eco-friendly, and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Lobeglitazone Sulphate and Glimepiride in combined tablet dosage forms. The chromatographic separation was carried out using an Inertsil C18 column with a mobile phase consisting of methanol and phosphate buffer (pH 4.5) in a 65:35 (v/v) ratio at a flow rate of 0.8 mL/min. Detection was performed at 230 nm, and the drugs were eluted at retention times of approximately 2.04 minutes and 7.45 minutes, respectively. The method was validated according to ICH Q2(R2) guidelines and showed excellent linearity, accuracy, precision, specificity, robustness, and sensitivity, with correlation coefficients of 0.999 and %RSD values below 2%. Forced degradation studies under different stress conditions confirmed the stability-indicating capability of the method. In addition, the method followed green analytical chemistry principles and achieved an AGREE score of 0.78, indicating good environmental sustainability. Therefore, the developed RP-HPLC method is reliable and suitable for routine quality control and stability analysis of these antidiabetic drugs in pharmaceutical formulations.