METHOD DEVELOPMENT AND VALIDATION OF ANTI-OBESITY DRUGS USING MODERN ANALYTICAL TOOLS: A COMPREHENSIVE REVIEW
1Puneeth Kumar K R, Chaithanya M P, *Dr. Ayushi Chawla, Dr. S. Vijaya Bhaskar, Dr. Shachindra L Nargund, Dr. Shravan L. Nargun
ABSTRACT
Obesity, characterized by excessive body fat accumulation and a Body Mass Index (BMI) of 30 or higher, has emerged as a critical global health concern. It contributes significantly to the risk of developing chronic diseases and has seen a steep rise in prevalence worldwide, including in India. This review article provides a comprehensive overview of obesity, its classifications, causes, and global trends. Emphasis is placed on the analytical method development of anti-obesity drugs, following ICH Q14 guidelines. Various modern analytical techniques—such as UV spectroscopy, HPLC, HPLC-MS/MS, gas chromatography, and HPTLC—are discussed in detail for their application in the quantification and assessment of drugs like Orlistat, Cetilistat, Semaglutide, etc. Each method is evaluated based on parameters like solvent, wavelength, retention time, precision, and recovery, highlighting their reliability and specificity in drug analysis. This work aims to support the standardization and optimization of pharmaceutical analysis to improve therapeutic outcomes in obesity treatment. Analytical method development, validation, and transfer are essential elements of any pharmaceutical development program. effective method development ensures that laboratory resources are optimised while methods meet the purpose required at each stage of drug development. With the increasing complexity of more than drug formulations, especially for Anti-Obesity drugs, there is a pressing need for reliable and reproducible analytical methods.
Keywords: Obesity, Anti-obesity, Analytical method development, Method Validation, ICH, Analytical techniques, Regulatory requirements.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
