Review on Analytical Method Development and V...

Review on Analytical Method Development and Validation of Trospium Chloride

Author Name : V S Thiruvengadarajan, M Vihashini, A Rajasekaran, I Ponnilavarasan, N Tamilselvi, L Sivakumar, V Dhilipkumar

ABSTRACT Trospium chloride is an antimuscarinic agent primarily used in the management of overactive bladder symptoms. The development and validation of reliable analytical methods for the quantification and quality control of Trospium chloride are crucial for ensuring its safety, efficacy, and regulatory compliance. This review presents an in-depth evaluation of various analytical techniques employed for the determination of Trospium chloride in pharmaceutical formulations, including high performance liquid chromatography (HPLC), ultraviolet (UV) spectrophotometry. Emphasis is placed on the principles, advantages, and limitations of these methods, as well as their application in routine quality control and pharmacokinetic studies. Furthermore, the review explores the regulatory guidelines for method validation, such as accuracy, precision, specificity, linearity, and robustness, essential for meeting the standards set by pharmaceutical regulatory authorities. By summarizing current methodologies and their validation parameters, this review aims to provide a comprehensive guide for researchers and analysts involved in the analytical testing of Trospium chloride and its formulations, ultimately contributing to the advancement of therapeutic monitoring and product quality assurance.