ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ANTIDIABETIC DRUGS: CURRENT TRENDS, CHALLENGES AND FUTURE PERSPECTIVES

Diabetes mellitus is a metabolic disorder characterized by hyperglycaemia and is mainly classified into type 1 and type 2 diabetes mellitus. Its pharmacological management includes insulin and several classes of antidiabetic drugs, creating a need for reliable analytical methods for drug identification, assay, purity assessment, stability testing, and quality control [1–3]. Analytical method development involves the systematic selection and optimization of suitable procedures for analysing active pharmaceutical ingredients (APIs), pharmaceutical formulations, impurities, degradation products, and, where applicable, biological samples. Commonly employed techniques include UV–Visible spectrophotometry, high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC/UHPLC), capillary electrophoresis (CE), and liquid chromatography–mass spectrometry (LC–MS). Method validation provides documented evidence that an analytical procedure is suitable for its intended purpose. Important validation characteristics include specificity, response and range, accuracy, precision, detection limit, quantitation limit, and robustness, as applicable [13,14]. This review discusses the classification of antidiabetic drugs, major analytical techniques, analytical method-development strategies, validation parameters, regulatory requirements, pharmaceutical applications, current challenges, recent trends, and future perspectives in the analysis of antidiabetic drugs.