Advances in analytical strategies for fixed-dose gliflozin combinations: A comprehensive evaluation

Fixed-dose combinations (FDCs) containing gliflozin derivatives have become important therapeutic options in type 2 diabetes, offering complementary mechanisms and improved treatment adherence. Their growing clinical use highlights the need for dependable analytical procedures to ensure quality, stability, and regulatory compliance. This review summarises the analytical approaches reported for the simultaneous determination of gliflozins with metformin, DPP-4 inhibitors, and other co-formulated agents in bulk materials, pharmaceutical dosage forms, and biological matrices. High-performance liquid chromatography (HPLC) remains the most widely used technique, while UPLC, LC–MS/MS, spectrophotometric methods, green analytical strategies, and AQbD-based developments have also been investigated. Although the literature demonstrates significant methodological progress, important gaps persist in impurity profiling, degradation behaviour, metabolite assessment, and broader implementation of ICH Q2(R2) and Q14 principles. By consolidating existing evidence and highlighting current limitations, this review aims to support the development of robust, reliable, and regulatory-aligned analytical methods for gliflozin-based FDCs.