RP-HPLC Methodology for Olanzapine Impurity Analysis: Advances in Development and Validation

Abstract

Olanzapine, an atypical antipsychotic drug, plays a critical role in the treatment of psychiatric disorders, necessitating the availability of reliable analytical methods for its quantification and quality assessment. Chromatography, particularly reverse-phase high-performance liquid chromatography (RP-HPLC), serves as the cornerstone of separation science in pharmaceutical research and development. This review highlights the development and validation of an RP-HPLC method tailored for olanzapine analysis, emphasizing its significance in drug discovery, development, and manufacturing processes. Validation ensures the method's reliability in determining key characteristics of olanzapine against established acceptance criteria. Parameters such as accuracy, precision, specificity, linearity, range, limits of detection (LOD) and quantification (LOQ), robustness, and system suitability are comprehensively assessed in compliance with ICH guidelines. By offering insights into the critical aspects of method development and validation, this review aims to provide a robust framework for ensuring the quality, efficacy, and safety of olanzapine formulations.