Development and validation of simple simultaneous analysis for olanzapine and samidorphan by reverse phase high performance liquid chromatography in table dosage form

https://doi.org/10.54037/WJPS.2022.100905

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Olanzapine and Samidorphan in bulk and pharmaceutical dosage form. Chromatogram was run through Std Zorbax 150 x 4.6 mm, 5mm. Mobile phase containing Buffer 0.01N Sodium hydrogen phosphate: Acetonitrile taken in the ratio 60:40 %v/v was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was 0.01N Na2hpo4 buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 268.0 nm. Retention time of Olanzapine and Samidorphan were found to be 2.235 min and 2.784 min. %RSD of the Olanzapine and Samidorphan were and found to be 0.4% and 0.7% respectively. %Assay was obtained as 99.19% and 99.81% for Olanzapine and Samidorphan respectively. %Recovery was obtained as 99.49% and 99.49% for Olanzapine and Samidorphan respectively. LOD, LOQ values obtained from regression equations of Olanzapine and Samidorphan were 0.21, 0.63 and 0.09, 0.23 respectively. Regression equation of Samidorphan is y = 31381x + 3743.6, y = 34206x + 4549.1of Olanzapine. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.