Optimized and Validated RP-HPLC Method for the Determination of Olanzapine in Pharmaceutical Formulations

Abstract

A simple, precise, accurate, rapid and reproducible RP-HPLC method has been developed for the determination of Olanzapine in pharmaceutical formulations. Chromatography was carried out on a reverse phase C-8 column (150 x 4.6 mm x 5 um length), optimum separation was achieved in 15 min using a mobile phase at a flow rate of 1 mL/min and the detection was done at 260 nm. The method produced linear responses in the concentration range from 45.2-135.6 μg/mL of Olanzapine with correlation coefficients of 1, accuracy of 99.80% and precision of 1.885%. The method was found to be reproducible for analysis of the drug in pharmaceutical formulations. The results of the analysis were tested and validated statistically for various parameters according to ICH guidelines and recovery studies confirmed the accuracy of the proposed method.