"Emerging Trends and Challenges In Bio-Analytical Method Development For Anti-Diabetic Drugs"

Abstract

Bio-analytical method development and validation are crucial in ensuring the accurate analysis of anti-diabetic drugs, which is vital for effective therapeutic monitoring and drug development. This comprehensive review focuses on the latest advancements and strategies in bio-analytical techniques for anti-diabetic drug analysis, with a particular emphasis on Liquid Chromatography-Mass Spectrometry (LC-MS/MS) as the preferred tool. We explore the classification and mechanisms of action of various anti-diabetic drugs, including biguanides, DPP-4 inhibitors, and SGLT2 inhibitors, and discuss the advantages of LC-MS/MS in overcoming the limitations of traditional methods. Key aspects such as sample preparation strategies, matrix effects, calibration, standardization, and regulatory requirements are addressed. The review also highlights emerging trends, including the integration of automation and artificial intelligence in method development, and identifies current challenges such as matrix complexity and analyte stability. Recommendations for future research focus on impurity profiling, stress degradation studies, and quantification of anti-diabetic drugs in human plasma. This review provides a comprehensive overview for researchers and practitioners aiming to enhance bio-analytical methodologies in the field of anti-diabetic drug analysis.