.

ISSN 2063-5346
For urgent queries please contact : +918130348310

RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR THE ESTIMATIONOF OSILODROSTAT IN API FORM.

Main Article Content

Ms. Janki Patel, Mr. Ronak Patel, Ms. Urvi Raval, Dr. Ankita Patel, Dr. Yogesh Patel, Dr. Divyakant Patel ,Ms. Margi Prajapati, Ms. Jinal Bihola
» doi: 10.31838/ecb/2023.12.si4.068

Abstract

For the management of Cushing Syndrome, osilodrostat is used. For the estimation of Osilodrostat, a straightforward, accurate, quick, and stability indicating RP-HPLC method was devised. C18 (250 4.6 mm, 5 mm) column and Phos. Buffer pH 3.2- MeOH (40:60) as the mobile phase were used to separate the samples at a flow rate of 1.0 ml/min. The detection process took place at 240 wavelengths. Osilodrostat was discovered to have a retention time of 5.160 minutes. For linearity, accuracy, precision, robustness, LOD, and LOQ, the technique has been validated. Osilodrostat has been found to be linear. Linearity observed for Osilodrostat 10-30 µg/ml. The LOD and LOQ were found 0.0015 µg/ml and 0.048 µg/ml respectively. The estimation of Osilodrostat in API form was successfully implemented using this technique.The RP-HPLC technique was discovered to be straightforward, precise, reliable, and repeatable

Article Details