Development and Validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) Method for the Quantification of Olanzapine and Its Impurity

Abstract

Olanzapine is an atypical antipsychotic drug, and chromatography is the backbone of separation science. It is utilized in all research laboratories and pharmaceutical industries throughout the world. The current review article focuses on the development and validation of an RP-HPLC method for olanzapine. Method development and validation are important in new drug discovery, development, and manufacturing, as well as a variety of other human and animal investigations. An analytical technique is developed to compare a defined characteristic of a drug substance or drug product to established acceptance criteria. Accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and system suitability testing are all covered by validation of HPLC methods according to ICH Guidelines.