Analytical method Development and validation of RP-UPLC method for the pharmaceutical dose estimation of Zuranolone Capsule dosage forms

A simple, sensitive, specific, and precise RP-UPLC method for the pharmaceutical dose estimation of Zuranolone Capsule dosage forms. Chromatogram was run through ACQUITY UPLC HSS T3 Column 1.8 µm, 2.1 mm X 100 mm. Mobile phase containing Acetonitrile: kh2po4 taken in the ratio 60:40 was pumped through column at a flow rate of 0.2ml/min. Temperature was maintained at 26.0°C. Optimized wavelength selected was 288.0nm. Retention time of Zuranolone was found to be 0.858 min. %RSD of the Zuranolone were and found to be 1.3. %RSD of Repeatability precision of Zuranolone was found to be 1.4. %Recovery was obtained as 99.68% for Zuranolone. %Assay was obtained as 99.80% for Zuranolone. LOD, LOQ values obtained from regression equation of Zuranolone were 0.10, 0.31. Regression equation of Zuranolone is y = 7342.2x + 572.56. 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