Development and Validation of an RP-UPLC Method for Rapid and Simultaneous Analysis of Samidorphan and Olanzapine with an Integrated Stability Study

The development of a straight forward, precise, and accurate method for the simultaneous estimation of Samidorphan and Olanzapine in their dosage forms took place ACQUITY UPLC BEH C18 Column, 1.7 μm, 2.1 mm X 100 mm, was used to run the chromatogram 0.1% OPA mobile phase containing buffer (4.6 pH): Acetonitrile, which was taken in a ratio of 55:45, was pumped through the column at a 0.2 ml/min flow rate. In this method 0.1% orthophosphoric acid was used as buffer. The temperature was kept at 30°C 264 nm was the preferred wavelength Samidorphan retention time was 0.669 minutes, while Olanzapine retention time was 0.880 minutes. Samidorphan %RSD was 0.3, while Olanzapine was found to be 0.9। % Recovery was 99.93% for Samidorphan and 100.26% for Olanzapine Samidorphan LOD and Olanzapine LOQ values were 0.05, 0.14, and 0.41, 1.24, respectively from their regression equations Samidorphan regression equation is y = 19497x + 10313, while Olanzapine equation is y = 23803x + 7958.2 The method was simple and cost-effective because retention times and run time were reduced.