Development And Validation Of A Novel Reverse-Phase HPLC Method For Impurity Profiling In Advanced Anti-Diabetic Drugs: Amycretin And Teplizumab

The study focuses on developing and validating a novel RP-HPLC method tailored for impurity profiling in Amycretin and Teplizumab, two advanced anti-diabetic drugs. Addressing challenges posed by complex impurity profiles and molecular structures, the method achieved high sensitivity with LOD and LOQ values of 0.02% and 0.05%, respectively, and precise separation of impurities under varied conditions. Validation adhered to ICH guidelines, confirming accuracy (98.5–101.2%), precision (RSD < 2%), and robustness. Stress studies revealed distinct degradation pathways; for instance, light exposure resulted in minimal impurity formation (0.12%) for Amycretin, while heat and basic conditions produced higher impurity levels (0.15%) for Teplizumab. Batch testing across 10 samples demonstrated consistent compliance with regulatory limits (≤ 0.20%). Optimized gradient profiles, along with column selection, ensured baseline resolution with retention times for APIs and impurities observed at 6.2 and 7.8 minutes for Amycretin, and 9.4 and 10.3 minutes for Teplizumab. The method's efficacy in identifying impurities and degradation products underscores its utility in routine quality control and regulatory compliance. This validated approach offers a robust tool for impurity profiling in pharmaceutical analysis, setting a benchmark for future studies aimed at enhancing drug safety and efficacy.