A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR LOBEGLITAZONE AND GLIMEPIRIDE IN BULK AND PHARMACEUTICAL FORMULATION

S. Gokulraj*, D. Rajalingam, N. Gnanasekar, A. Siva, K. Sivaramakrishnan, S. K. Harshini

Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disorder characterized by insulin resistance and impaired insulin secretion, requiring effective combination therapy for optimal glycemic control. Lobeglitazone, a thiazolidinedione and potent PPAR-γ agonist, enhances insulin sensitivity in peripheral tissues, while Glimepiride, a third-generation sulfonylurea, stimulates pancreatic β-cells to increase insulin secretion. The fixed-dose combination of these agents provides complementary mechanisms that improve fasting and postprandial glucose levels, reduce HbA1c, and enhance patient compliance. With the growing clinical use of this combination, the development and validation of reliable analytical methods are essential to ensure quality, safety, efficacy, and regulatory compliance. This review comprehensively summarizes physicochemical properties, pharmacokinetics, pharmacodynamics, adverse effects, drug interactions, pharmacovigilance data, regulatory approvals, and marketed formulations of Lobeglitazone and Glimepiride. Emphasis is placed on reported analytical techniques for simultaneous estimation in bulk and dosage forms, including RP-HPLC, HPLC, UPLC, UV–Visible spectrophotometry, and HPTLC, along with validation parameters such as accuracy, precision, linearity, specificity, robustness, LOD, and LOQ in accordance with ICH guidelines. Comparative evaluation indicates that RP-HPLC remains the most widely accepted and reliable method for routine quality control, while emerging green analytical approaches offer sustainable alternatives.