“INNOVATIVE APPROACHES IN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR EVOGLIPTIN TARTRATE AND ITS MULTI-DRUG COMBINATIONS”

As pharmaceutical formulations become more complex—especially in the management of type 2 diabetes—there is a growing need for advanced analytical techniques to accurately assess drug content. This work presents innovative strategies for the development and validation of analytical methods tailored to Evogliptin tartrate, both as a standalone compound and in fixed-dose combinations with other antidiabetic agents. Due to the absence of official pharmacopoeial methods for newer drugs like Evogliptin, novel approaches utilizing UV spectrophotometry, high-performance liquid chromatography (HPLC), and LC-MS were investigated. The methods were developed following ICH guidelines and rigorously validated for parameters such as specificity, linearity, accuracy, precision, and sensitivity. These validated methods are designed to ensure reliable quality control and regulatory compliance for Evogliptin-containing formulations, ultimately supporting the safety and therapeutic effectiveness of modern antidiabetic treatments.