Method Development and Validation for Simultaneous Estimation of Samidorphan, Olanzapine in pharmaceutical Dosage Form by RP- HPLC

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Samidorphan and Olanzapine in bulk and pharmaceutical dosage form. Chromatogram was run through Std BDS 150 x 4.6 mm, 5mm. Mobile phase containing Buffer 0.01N Potassium dihydrogen phosphate: Methanol taken in the ratio 80:20 %v/v was pumped through column at a flow rate of 0.9 ml/min. Buffer used in this method was 0.01N Kh2po4 buffer. Temperature was maintained at 29°C. Optimized wavelength selected was 278.0 nm. Retention time of Samidorphan and Olanzapine were found to be 2.365 min and 3.108 min. %RSD of the Samidorphan and Olanzapine were and found to be 0.6% and 0.4% respectively. %Recovery was obtained as 100.29% and 100.46% for Samidorphan and Olanzapine respectively. LOD, LOQ values obtained from regression equations of Samidorphan and Olanzapine were 0.29, 0.89 and 0.04, 0.12 respectively. %Assay was obtained as 99.71% and 99.58% for Samidorphan and Olanzapine respectively. Regression equation of Samidorphan is y = 21331x + 3547.4, y = 29592x + 9783.5 of 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